System and method for interrupting nerve activity to treat a medical condition

Abstract

Devices, systems, and methods are provided for treating or preventing heart failure or symptoms of heart failure via disruption of coordinated neural activity to one or more target nerves. The devices disclosed herein may comprise a vascular catheter comprising a flexible needle assembly configured to puncture vascular tissue in contact with the catheter, the needle assembly comprising one or more electrodes configured to deliver electrical energy to tissue in contact with the one or more electrodes. The methods may include treating or preventing heart failure or symptoms of heart failure by inserting a catheter into the vascular tissue of a subject, guiding the catheter toward a larger visceral nerve, puncturing the vascular tissue of the subject with a flexible needle assembly extending outwardly from the catheter toward the target nerve, and ablating the target nerve by delivering stimulating energy to the target nerve with one or more electrodes.

Description

Technical Field

[0001] Cross-reference This application claims priority to the benefit of U.S. Patent Application No. 17 / 841,424, filed on Jun. 15, 2022, now issued as U.S. Patent No. 11,672,595, a portion of which is continuing, and U.S. Patent Application No. 18 / 310,411, filed on May 1, 2023, which is a continuation of U.S. Patent Application No. 17 / 841,424, filed on Jun. 15, 2022, each of which is hereby incorporated by reference in its entirety.

Background Art

[0002] Heart failure affects more than 6 million subjects. In some instances, heart failure is characterized by muscle weakness and results in inefficient heart pumping. As a result, in some instances of heart failure, forward blood flow is poor and can cause blood backup and the accumulation of pressure in the heart and lung circuits. Thus, the blood pressure within the heart increases, resulting in symptoms such as the onset of congestion, shortness of breath, and / or respiratory failure. In some instances, conventional methods for reducing the pressure-volume load on the cardiopulmonary circuit include removing fluid accumulation (e.g., fluid in blood vessels and tissues), thereby potentially reducing heart failure symptoms. However, current standard treatments for treating heart failure patients often only include agents such as ACE inhibitors, angiotensin-2 receptor blockers (ARBs), beta blockers, mineralocorticoid receptor antagonists, diuretics, ivabradine, sacubitril valsartan, hydralazine in combination with nitrates, and / or digoxin, and are aimed at reducing the pressure-volume load on the cardiopulmonary circuit. There remains a need in the art for alternative methods of treating heart failure other than with agents.

Summary of the Invention

[0003] The inventors understand that the treatment of heart failure or its symptoms can be achieved by nerve ablation to the branches of the visceral nerves, and that such alternative treatment can improve the current drug-based standard treatment for heart failure patients. The inventors further understand that the current drug-based standard treatment is insufficient for many heart failure patients, and that the treatment of heart failure can be improved by nerve ablation.

[0004] For example, common symptoms of heart failure include an increase in blood pressure within the heart and the accumulation of blood within the cardiopulmonary circuit. When a subject suffers from late-stage heart failure, with standard therapeutic agents, for example, due to low bioavailability of the agent or the fact that it takes a significant amount of time to pharmacologically reduce fluid accumulation in the body, it may take too long to lower the intracardiac pressure to prevent hospitalization. Other patients prescribed drugs for standard treatment to lower intracardiac pressure may not respond to the drugs, may not be able to take certain agents due to drug interactions or other co-existing diseases, or may require non-standardized drug dosages to achieve efficacy, all of which can limit the effectiveness of the agent. In other cases, subjects suffering from early-stage heart failure may not meet the hospitalization criteria for treating heart failure and may be refused hospitalization until the condition becomes critical. Most heart failure patients could benefit from a non-drug-based approach to treating heart failure or its symptoms, particularly patients at risk of worsening heart failure who do not yet meet the hospitalization criteria, for example, patients rated 2 - 3 on the New York Heart Association 1 - 4 assessment scale.

[0005] Accordingly, a method of treating heart failure or its symptoms by inactivating the greater visceral nerves is disclosed herein. Nerve ablation of the greater visceral nerves can inactivate aspects of the sympathetic nervous system, reduce intracardiac pressure and the accumulation of blood within the cardiopulmonary circuit, and reduce the likelihood that heart failure patients will require hospitalization without the need for pharmacological intervention.

[0006] The inventors further understand that current devices and methods for larger visceral nerve ablation may utilize electrode assemblies that are prone to failure or may cause unnecessary trauma to vascular and surrounding tissues compared to what is required for nerve ablation. For example, current methods for destroying larger visceral nerves may include open-heart surgery that requires opening the sternum, reflection of vital organs (including the heart and lungs) to access the visceral nerve, and physically lysing the nerve with a scalpel or other device. Such procedures are highly invasive and cause increased strain on the subject's heart, which is unacceptable for subjects already suffering from heart failure. Another method used for larger visceral nerve ablation involves puncturing the subject's back with a needle, driving the needle through the subject's aorta, and accessing the larger visceral nerve, which poses a significant risk to surrounding organs including the lungs, heart, and aorta. In other cases, non-stereoscopic electrode assemblies utilized for nerve ablation may induce sharp-force trauma to vascular tissue and the tissue surrounding the target nerve. Accordingly, the aspects disclosed herein provide a nerve ablation catheter device that can be used to access larger visceral nerves through the subject's vascular system and includes an improved needle assembly that does not require puncturing the aorta with a needle to access the larger visceral nerve. Such devices enable nerve ablation to the branches of the visceral nerve in a less invasive manner that does not exert increased strain on the subject's heart and minimizes sharp-force trauma to vascular tissue and the tissue surrounding the target nerve, and may be particularly useful for implementing a method of treating heart failure or the symptoms described herein. Such improved needle assemblies may also more easily experience reduced manufacturing and error rates due to preventing tissue adhesion to the inner surface of the needle assembly.

[0007] Aspects disclosed herein provide a method of doing so in a subject in need of treating or preventing heart failure or symptoms of heart failure, the method comprising inserting a catheter into a vascular lumen defined by the subject's vascular tissue, guiding the catheter towards a location proximal to the target nerve, wherein the target nerve includes a greater splanchnic nerve, puncturing the subject's vascular tissue with a flexible needle assembly extending outwardly from the catheter towards the target nerve, wherein the flexible needle assembly comprises an electrode assembly, the flexible needle assembly having a first section surrounding a second section, the second section extending outwardly from the first section, delivering stimulation energy to the target nerve using the electrode assembly, thereby ablating the target nerve completely or partially and treating or preventing heart failure or symptoms of heart failure in the subject. In some embodiments, treating or preventing heart failure or symptoms of heart failure in the subject includes reducing intracardiac blood pressure or reducing blood accumulation in the subject's cardiopulmonary circuit. In some embodiments, the method further comprises delivering pre-stimulatory energy to the target nerve before puncturing the subject's vascular tissue, or delivering pre-stimulatory energy to the target nerve after puncturing the subject's vascular tissue, or a combination thereof, measuring a physiological response corresponding to the pre-stimulatory energy, thereby indicating whether the location proximal to the target nerve is sufficiently close to the target nerve. In some embodiments, the physiological response includes neural activity, muscle movement, cardiac activity, adverse changes in pulmonary capillary wedge pressure (PCWP), gastrointestinal changes including increased motility, increased or decreased sweating of the palm, increased or decreased temperature for rectal and / or skin measurements, increased or decreased renal output in response to changes in vasodilation, decreased metabolism, decreased glucose release, decreased glucagon release, or increased brain natriuretic peptide. In some embodiments, the physiological response includes measuring action potentials through the target nerve. In some embodiments, an inadequate physiological response corresponding to the pre-stimulatory energy is measured, indicating that the location proximal to the target nerve is not sufficiently close to the target nerve.In some embodiments, the method further includes redirecting the catheter towards a second location proximal to the target nerve, the second location being closer to the target nerve than the first location. In some embodiments, a sufficient physiological response corresponding to the pre-stimulus energy is measured, indicating that the location proximal to the target nerve is sufficiently close to the target nerve. In some embodiments, the stimulus energy sufficient to ablate the target nerve includes electrical stimulation. In some embodiments, delivering to the target nerve the stimulus energy sufficient to ablate the target nerve using the electrode assembly includes heating the target nerve or a portion thereof to about 50, 55, 60, 65, 70, 75, 80, 85, or 90 °C. In some embodiments, the method further includes orienting the catheter within the vascular tissue of the subject such that the needle assembly is in a direction aligned with the target nerve. In some embodiments, the method further includes orienting the catheter within the vascular tissue of the subject using an X-ray marker such that the needle assembly is in a direction aligned with the target nerve. In some embodiments, orienting the catheter includes orienting the needle assembly in a direction aligned with the target nerve. In some embodiments, orienting the catheter includes rotating the catheter such that the needle assembly extends from the catheter to the target nerve. In some embodiments, the method further includes delivering a confirmation stimulus energy after ablation of the target nerve, measuring the physiological response corresponding to the confirmation stimulus energy, or a change in the physiological response, thereby confirming the interrupted nerve activity of the target nerve. In some embodiments, a physiological response corresponding to the confirmation stimulus energy is measured, indicating that the ablation of the target nerve has failed. In some embodiments, the method further includes delivering the stimulus energy to the target nerve using the electrode assembly, thereby repeating the ablation of the target nerve. In some embodiments, the target nerve is the greater splanchnic nerve. In some embodiments, the target nerve is the left branch, right branch, smaller branch, or smallest branch of the greater splanchnic nerve.In some embodiments, guiding the catheter toward a location proximal to the target nerve includes guiding the catheter toward the ninth thoracic vertebra (T9), the tenth thoracic vertebra (T10), the eleventh thoracic vertebra (T11), the twelfth thoracic vertebra (T12), or the first lumbar vertebra (L1). In some embodiments, the stimulation energy is from about 10 W to about 100 W. In some embodiments, the stimulation energy is from about 25 W to about 75 W. In some embodiments, the stimulation energy is about 30, 35, 40, 45, 50, 55, 60, 65, or 70 W. In some embodiments, the stimulation energy is about 50 W.

[0008] Aspects disclosed herein provide a vascular catheter, the vascular catheter comprising a longitudinal axis, a distal end, a proximal end, a catheter shaft having an exit port, a needle assembly lumen extending through the exit port and including a flexible needle assembly configured to pierce vascular tissue in contact with the catheter, the needle assembly comprising one or more electrodes configured to deliver electrical energy to tissue in contact with the one or more electrodes, the flexible needle assembly comprising a first section surrounding a second section, the second section extending outwardly from the first section, the needle assembly lumen, a guidewire lumen, and a catheter tip. In some embodiments, the vascular catheter further comprises a contrast lumen. In some embodiments, the exit port is positioned on a side surface of the catheter shaft. In some embodiments, the catheter further comprises an electrical surface on the needle assembly. In some embodiments, the catheter further comprises a base electrode on an outer surface of the catheter. In some embodiments, the base electrode is positioned within 0 to 90 degrees radially from a location on the outer surface of the vascular catheter relative to the longitudinal axis of the vascular catheter on its outer surface. In some embodiments, the catheter further comprises a plurality of base electrodes on an outer surface of the catheter. In some embodiments, the catheter further comprises a first electrical circuit electrically coupled to the one or more electrodes. In some embodiments, the catheter further comprises a second electrical circuit electrically coupled to the base electrode. In some embodiments, the catheter is configured to provide electrical energy of different frequencies to the first electrical circuit and the second electrical circuit. In some embodiments, the needle assembly comprises one or more tubular bodies, a distal point, a first electrode, a second electrode, a wire connecting the first electrode and the second electrode to a power source, and an insulating material insulating the first electrode, the second electrode, and the wire from the vascular catheter. In some embodiments, the wire comprises an enamel-coated wire or a multi-strand braid.In some embodiments, the first section includes a first tubular body, the second section includes a second tubular body, the first tubular body extends outwardly from the second tubular body, the first tubular body is nested within the second tubular body, whereby the tubular body is completely or partially received within the first tubular body. In some embodiments, the needle assembly further includes a third section including a sharp distal end, the second section surrounds the third section, and the third section extends outwardly from the second section. In some embodiments, the first electrode is positioned on the first tubular body and the second electrode is positioned on the second tubular body. In some embodiments, the first electrode and the second electrode are positioned on the first tubular body or on the second tubular body. In some embodiments, the needle assembly further includes an electrical insulating material within the needle assembly, and the electrical insulating material includes a dielectric insulator between the first tubular body and the second tubular body. In some embodiments, the needle assembly further includes an electrical insulating material within the needle assembly, and the electrical insulating material includes an insulator or a dielectric washer positioned between the first tubular body and the second tubular body along the circular cross-section of the first tubular body or the second tubular body. In some embodiments, the one or more electrodes include only a single electrode. In some embodiments, the one or more electrodes include two electrodes. In some embodiments, the one or more electrodes include three electrodes. In some embodiments, the three electrodes are arranged such that the second electrode is between the first electrode and the third electrode, the second electrode is a negative electrode, and the first and third electrodes are positive electrodes, or adjacent electrodes have opposite polarities. In some embodiments, the three electrodes are arranged such that the second electrode is between the first electrode and the third electrode, the second electrode is a positive electrode, and the first and third electrodes are negative electrodes. In some embodiments, the catheter is configured to enable ablation between the first electrode and the second electrode, or between the second electrode and the third electrode. In some embodiments, the needle assembly further includes an electrical insulating material within the needle assembly. In some embodiments, the electrical insulating material includes a dielectric, a dielectric washer, or a polyimide liner. In some embodiments, the needle assembly further includes a third electrode. In some embodiments, the needle assembly further includes a separate electrical circuit for each electrode.In some embodiments, the needle assembly extends a predetermined distance from the exit port, is proximate to the target nerve, and when energized, the vascular catheter is configured to ablate a target nerve that is at least as long as or longer than the deployment distance between the first tubular body and the second tubular body. In some embodiments, the insulating material includes a dielectric washer. In some embodiments, the first electrode and the second electrode are electrically isolated from each other. In some embodiments, the needle assembly is configured to deliver charge in a bipolar mode. In some embodiments, the first electrode and / or the second electrode are operably communicatively coupled with a controller configured to regulate the power delivered by an energy source. In some embodiments, one or more electrodes include silk screen electrodes. In some embodiments, one or more electrodes include additive manufacturing electrodes. In some embodiments, one or more electrodes include subtractive manufacturing electrodes. In some embodiments, the catheter further includes a base at a proximal end of the vascular catheter configured to enable manipulation of the vascular catheter. In some embodiments, the catheter further includes a vascular catheter rotation knob configured to rotate the vascular catheter. In some embodiments, the catheter further includes a rotary electrical connector configured to rotate the catheter or the needle assembly. In some embodiments, the catheter further includes a rotary electrical connector configured to rotate the catheter, the needle assembly, the guide wire port, or the contrast port. In some embodiments, the catheter further includes a rotary electrical connector configured to rotate the catheter or the rotation control knob. In some embodiments, the catheter further includes a rotary coupler configured to rotate the vascular catheter. In some embodiments, the catheter further includes an electrode advance device configured to extend the needle assembly and one or more electrodes through the exit port. In some embodiments, the catheter further includes a guide wire port. In some embodiments, the catheter further includes a contrast port. In some embodiments, the catheter further includes a dielectric material that insulates one or more electrodes from the vascular catheter. In some embodiments, the dielectric material includes polyimide.In some embodiments, the vascular catheter shaft comprises braided reinforced Pebax, an extruded material, nylon, fibrous material, wire, a multi-distortion braid, or a material configured to transmit force through the longitudinal axis. In some embodiments, the needle assembly further comprises one or more marker bands. In some embodiments, the marker band provides an indication regarding the positioning of the catheter relative to a vein and is configured to indicate the relative position of the catheter within a vein, artery, or blood vessel by fluoroscopic imaging. In some embodiments, the needle assembly further comprises a bifurcated configuration including a second tubular body terminating in a sharp point, the first and second tubular bodies being spaced apart when the needle assembly extends and the first electrode is on the first tubular body and the second electrode is on the second tubular body.

Brief Description of the Drawings

[0009] For a more complete understanding of the invention, including its features and advantages, reference is now made to the detailed description of the invention in conjunction with the accompanying drawings.

[0010]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Figure 12

Figure 13

Figure 14

Figure 15

Figure 16

Figure 17

Figure 18

Figure 19

Figure 20

Figure 18 - 21

Figure 22

Figure 23A

Figure 23B

Figure 24A

Figure 24B

Figure 25A

Figure 25B

Figure 26A

Figure 26B

Figure 27A

Figure 27B

Figure 28

Figure 29A

Figure 29B

DETAILED DESCRIPTION OF THE INVENTION

[0011] Provided herein are devices, systems, and methods for treating a medical condition via disruption of coordinated neural activity to one or more target nerves. In some embodiments, the disruption of neural activity induces a response for treating the medical condition, including reducing the symptoms of the medical condition. In some embodiments, the disruption of neural activity includes destroying a portion of one or more target nerves. In some embodiments, destroying a portion of one or more target nerves includes targeting the target nerves at one or more different locations to enable such destruction. In some embodiments, a bifurcated needle assembly having two needles (e.g., needle electrodes as described herein) with the tips of each needle spaced apart provides ablation of a desired length along the length of the target nerve, and as a result, increases the duration of treatment of the medical condition and further minimizes collateral damage, and is introduced using a device (e.g., a catheter-based device) that enables ablation of the target nerve at one or more different locations. In some embodiments, the location of the target nerve is confirmed via any combination of fluoroscopy, nerve stimulation, and / or nerve sensing to ensure accurate ablation of the target nerve. For example, in some embodiments, nerve stimulation enables real-time or substantially real-time confirmation of the target nerve location.

[0012] In some embodiments, the medical condition includes heart failure such as inefficient heart pumping action, where disruption of a target nerve such as a visceral nerve (e.g., denervation of the target nerve) can reduce heart blood pressure by removing fluid in blood vessels and tissues (e.g., accumulation of blood in the heart) and sending the removed fluid to the abdominal cavity.

[0013] Medical condition In some embodiments, the systems, devices, and methods described herein are used to treat medical conditions. In some embodiments, as described herein, medical conditions include heart failure, constipation, metabolic syndrome (including obesity), hyperhidrosis, hypertension, or other conditions known in the art to be affected by disruption of neural activity of one or more target nerves, or combinations thereof.

[0014] Heart failure affects over 6 million subjects. In some instances, heart failure is characterized by muscle weakness, resulting in inefficient heart pumping. As a result, in some instances of heart failure, forward blood flow is poor, which can cause blood backup and the accumulation of pressure in the heart and lung circuits. Thus, blood pressure within the heart increases, leading to symptoms such as the onset of congestion, shortness of breath, and / or respiratory failure. In some instances, conventional methods for reducing the pressure-volume load on the cardiopulmonary circuit are by removing fluid (e.g., the accumulation of fluid such as blood) within blood vessels and tissues, thereby potentially reducing heart failure symptoms.

[0015] In some instances, the subject is in a state of compensated heart failure with no heart-lung pressure or symptoms. In some instances, such recovery of the heart in a state of compensated heart failure occurs with the use of drugs. In some instances, the subject is caught in a vicious cycle of volume accumulation, hospitalization due to fluid removal, and discharge, and heart recovery does not occur. In some instances, such subjects do not respond to conventional drugs.

[0016] Thus, in some embodiments, the systems, methods, and devices described herein are configured to provide a mechanical reduction of intracardiac pressure, for example, by redistributing fluid (e.g., blood) away from the heart to reduce intracardiac pressure.

[0017] In some embodiments, fluid (e.g., blood) is redistributed from the heart to one or more cavities within the subject (e.g., blood vessels within the cavity). In some instances, the abdominal cavity has a high vascular volume to absorb fluid. Thus, in some instances, cardiac benefit may result by introducing a mechanism for redistributing fluid from the cardiopulmonary circuit to the abdominal cavity. In some instances, vascular volume is determined by various factors including autonomic nerve activity. A part of the sympathetic nerve that induces the abdominal cavity includes the splanchnic nerve, where the splanchnic nerve is derived from the sympathetic chain within the thoracic cavity, moves to the abdominal cavity, and synapses on various ganglia there. Splanchnic nerve activity of the sympathetic nerve results in vasoconstriction within the abdominal cavity. Thus, in some embodiments, the systems, methods, and devices described herein are configured to inactivate sympathetic nerve activity (splanchnic nerve) to vasodilate the splanchnic vasculature and thereby draw fluid into the abdominal cavity. In some instances, there are multiple types of interventions for interrupting splanchnic nerve activity to achieve splanchnic vasodilation. In some embodiments, such multiple types include percutaneous means, transvascular means, and / or surgical means.

[0018] Method for reducing cardiac blood pressure Figure 1 provides an exemplary method for reducing cardiac blood pressure by redistributing fluid (e.g., blood) from the heart to one or more cavities. In some embodiments, the method includes interrupting the neural activity (e.g., denervation) of one or more target nerves. In some embodiments, the one or more target nerves are first identified and / or confirmed via one or more sensing techniques described herein, and then the neural activity of the one or more target nerves is interrupted. In some embodiments, a device described herein (e.g., a catheter-based device) is used to identify and / or confirm the location of one or more target nerves and / or interrupt the neural activity of one or more target nerves. As described herein, the one or more target nerves include visceral nerves, lumbar sympathetic nerves, sympathetic ganglia, other target nerves known in the art, or any combination thereof. As described herein, in some embodiments, the visceral nerves enable the treatment of heart failure (as described herein). Examples of branches of the visceral nerves include the greater splanchnic nerve (GSN), the lesser splanchnic nerve, and the least splanchnic nerve, any of which can be targeted (in combination or alone) for the treatment of a medical condition. For example, in some instances, the GSN is a branch of the thoracic sympathetic nerves and is thus configured to provide sympathetic innervation to the abdomen. The GSN can traverse the thorax, move through the aortic hiatus, progress to synapse on the celiac ganglia, and from there migrate internally to several target organs including the abdominal vasculature. Thus, by inactivating the GSN, the abdominal vasculature dilates, thereby withdrawing blood volume from the circulatory system. As described herein, in some instances, the volume withdrawn from the heart reduces the pressure load on the cardiopulmonary system, which can be evidenced, for example, by a decrease in the pulmonary capillary wedge pressure (PCWP) as described herein.

[0019] In some embodiments, targeting the lumbar sympathetic nerves enables the treatment of peripheral arterial disease. In some embodiments, targeting the sympathetic ganglia enables the treatment of ventricular arrhythmias.

[0020] For the exemplary method described in FIG. 1, the target nerve includes the visceral nerve, and the cavity that receives the redistributed fluid (e.g., blood flow) includes the abdominal cavity.

[0021] Identification of the Target Nerve In some embodiments, the devices described herein (e.g., catheter-based devices) are used to first approach the location of the target nerve, and then the target nerve is identified and / or confirmed to ensure that the correct nerve is targeted for interruption of nerve activity to obtain the desired effect. In some embodiments, confirmation of interruption of nerve activity at the target nerve serves as an exemplary identifier that a desired effect has occurred within the subject (e.g., treatment of a medical condition such as a decrease in intracardiac blood pressure).

[0022] In some embodiments, the device is used to access a target nerve (e.g., the visceral nerve) within the subject. In some embodiments, the devices described herein are used. In some embodiments, the device is a catheter-based device. In some embodiments, the device is inserted 102 into the subject. In some embodiments, the device is used to access the vasculature (e.g., via the femur and / or subclavian). In some embodiments, the device accesses the vasculature to inactivate sympathetic nerve activity. In some embodiments, the device accesses the vasculature via the Seldinger technique. In some examples, the access points for the vasculature of the upper limb include the jugular vein and / or the subclavian vein. In some examples, the access points for the vasculature in lower limb access include the femoral vein. Thus, in some embodiments, the devices described herein are configured to move from any of the jugular vein, subclavian vein, and / or femoral vein to the superior vena cava. In some embodiments, the device is navigated under fluoroscopic guidance. FIG. 22 provides an exemplary depiction of the anatomical structure of the visceral nerve and vein.

[0023] In some embodiments, the device is first moved to an approximate location of the target nerve within the target 104. In some embodiments, such approximate locations are based on the use of anatomical landmarks. In some embodiments, the device is guided to an approximate location of the target nerve under fluoroscopy taking into account the anatomical landmarks. In some embodiments, the anatomical landmarks include radiopaque anatomical landmarks. For example, in some embodiments, the device accesses the anastomotic vein 2202 (via an access point as described herein) which is a branch of the superior vena cava. In some embodiments, the device is configured to enter the left and / or right interhemorrhoidal vein branch 2204. In some embodiments, the device enters the left and / or right interhemorrhoidal vein branch via an anatomical landmark. In some embodiments, the anatomical landmark includes the ninth thoracic vertebra (T9) 2208 (shown as being located behind the intersection of the greater splanchnic nerve (GSN) 2206 and the left and / or right intercostal vein branch 2204), and the exemplary target nerve, the greater splanchnic nerve (GSN) 2206 is located near T9. Thus, the location of the GSN can be approximated via T9. As described herein, in some embodiments, the device is further configured to confirm the location of the target nerve (e.g., GSN) by directly sensing and / or stimulating the nerve while measuring a physiological response.

[0024] In some embodiments, in addition to or in lieu of using anatomical landmarks to approximate the location of the target nerve, the devices described herein use neuroperception to approximate the location of the target nerve. In some embodiments, the device includes a neuroperception region configured to detect action potential signals indicative of the presence of nearby nerves (relative to the device). In some embodiments, as described herein, the neuroperception region comprises one or more neuroperception electrodes.

[0025] In some embodiments, the devices described herein are configured to stimulate a target nerve to induce a nerve response such that the location and / or identity of the target nerve can be confirmed 106. In some embodiments, the device comprises a nerve stimulation component for stimulating the target nerve. In some embodiments, the device is configured to deliver charge to a subject via the nerve stimulation component to induce a nerve response from the target nerve (e.g., GSN). In some embodiments, the nerve stimulation component is configured to deliver charge through one or more nerve stimulation electrodes. In some embodiments, the nerve stimulation component (e.g., one or more nerve stimulation electrodes) is configured to deliver charge intravascularly (e.g., in a vein, artery, or blood vessel) and / or extravascularly (e.g., in a vein). In some embodiments, the device is configured to position one or more nerve stimulation electrodes to pierce through a blood vessel (e.g., a vein) and contact the target nerve or place the nerve stimulation electrodes in the vicinity of the target nerve to deliver charge. In some embodiments, the device is configured to deliver charge that is strong enough to induce a nerve response but not strong enough to damage tissue (e.g., target nerve tissue and / or surrounding tissue). In some embodiments, proximity of the device location to the target nerve (e.g., GSN) is confirmed by inducing one or more sympathetic nerve responses by delivering the charge 107. In some embodiments, such sympathetic nerve responses can be detected via a measured physiological response. In some embodiments, examples of detecting a sympathetic nerve response of the GSN via a measured physiological change include detecting an adverse change in pulmonary capillary wedge pressure (PCWP) (e.g., an increase in PCWP), gastrointestinal changes including an increase in motility, a change in the amount of sweating reduction on the palm, an abnormal change in temperature for rectal and / or skin measurements, an abnormal change in renal output associated with a change in vasodilation, a change in metabolism (i.e., a decrease in glucose and glucagon release), and / or an increase in brain natriuretic peptide. In some embodiments, the devices described herein are configured to detect and measure any of such indicators for a sympathetic nerve response.In some embodiments, any such indicators for sympathetic nerve responses are detected by using medical techniques and / or devices known in the art.

[0026] For example, in some instances, PCWP is obtained using a right heart catheterization procedure routinely performed in a hospital. An example of such a right heart catheterization procedure includes percutaneous access of a catheter through the jugular vein in a sterile manner (e.g., by using the Seldinger technique). In some embodiments, the catheter (for obtaining PCWP) may include a Swan-Ganz catheter having a balloon. In some embodiments, the balloon of the Swan-Ganz catheter is inflated and passed through the superior vena cava, right atrium, and right ventricle with respect to the pulmonary outflow tract. In some embodiments, the inflated balloon carries the catheter into the pulmonary artery, where the catheter is wedged and the detected pressure is called the pulmonary capillary wedge pressure. In some instances, PCWP is considered equivalent to the left ventricular pressure. In some instances, the left ventricular pressure is an alternative measurement of the left ventricular end-diastolic pressure. Thus, in some instances, PCWP is a measure of the severity of heart failure, and the higher the PCWP, the worse the severity of heart failure.

[0027] In some embodiments, in addition to, or instead of, detecting a physiological response to confirm the location of the target nerve, the location of the target nerve can be confirmed by detecting action potentials from the target nerve using a nerve sensory area.

[0028] As described herein, in some embodiments, the detection of each of the other responses induced through stimulation of the target nerve is measured by the devices described herein and / or by other respective devices and methods known in the art.

[0029] In some embodiments, the devices described herein (e.g., catheter devices) are configured to deliver charge to provide neural stimulation of a target nerve so as to sense the presence of the nerve (e.g., the target nerve) and to induce a sympathetic response therefrom, and / or to detect and measure a sympathetic response and / or action potential by the target nerve. For example, in some embodiments, the device may include one or more neural sensing electrodes and is configured to directly sense the target nerve through a neural sensing region as described herein. In some embodiments, the one or more neural sensing electrodes and one or more neural stimulation electrodes (for delivering charge to the target nerve as described herein) are separate sets of electrodes. In some embodiments, the one or more neural stimulation electrodes are also configured to function as neural sensing electrodes. In some embodiments where the device has separate sets of electrodes for neural sensing and neural stimulation, or the same set of electrodes for such functions, the device is further configured to change from a neural sensing mode to a neural stimulation mode to stimulate the target nerve. In some embodiments, the methods described herein include placing the device in the neural sensing mode when positioned proximate to the GSN (e.g., via the T9 landmark) to confirm the presence of a nerve nearby. In some embodiments, the device is configured to operate the neural sensing mode and the neural stimulation mode simultaneously. In some embodiments, as described herein, when in the neural sensing mode, the device uses electrodes and / or other components to detect an action potential and indicate the presence of a nearby nerve. In some embodiments, the devices described herein (e.g., catheter-based devices) are operably communicable with a computing device. In some embodiments, data from the neural stimulation component and / or the neural sensing component (of the same device) is transmitted to the computing device. In some embodiments, data from the neural stimulation component and / or the neural sensing component is aggregated to indicate that the device is at a location for performing a neurodestruction to interrupt neural activity. Interruption of Target Nerve Activity

[0030] In some embodiments, when the location of a target nerve (e.g., the GSN) is identified (e.g., via nerve stimulation and / or nerve sensing as described herein), the nerve activity of the target nerve is interrupted 108. In some embodiments, such identification of the target nerve location includes, for example, by a physiological response as described herein that measures a response (e.g., a sympathetic response) to the stimulated target nerve and / or by detecting an action potential of the target nerve. In some embodiments, identifying the location of the target nerve includes a combination of a nerve stimulation function and a nerve sensing function that is evaluated by software components of the computing device described herein.

[0031] In some embodiments, interrupting neural activity includes ablating the target nerve. In some embodiments, the devices described herein are configured to ablate a portion of a target nerve (e.g., the GSN). In some embodiments, ablation of the target nerve includes circumferentially lysing the target nerve. As described herein, the device can be configured to ablate a portion of the target nerve using a plurality of different methods. For example, in some embodiments, the device comprises a vascular access mechanism for performing ablation. In some embodiments, the vascular access mechanism operates in the direction of the nerve to perform ablation. In some embodiments, the vascular access mechanism is also configured to confirm the position of the device using a combination of 1) nerve sensing, 2) nerve stimulation with a physiological response, and / or 3) fluoroscopy to identify anatomical landmarks (e.g., the 9th thoracic vertebra (T9), 10th thoracic vertebra (T10), 11th thoracic vertebra (T11), 12th thoracic vertebra (T12), or 1st lumbar vertebra (L1)). In some embodiments, the device is configured to destroy a portion of the target nerve (a portion of the GSN) using one or more of the following modalities: radiofrequency ablation, chemical ablation (carbon dioxide, ethanol, liquid nitrogen), or cryoablation. In some embodiments, in addition to or instead of ablation of the target nerve, the devices described herein are configured to downregulate a portion of the target nerve.

[0032] As described herein, destroying a portion of a target nerve (e.g., via ablation) corresponds to destroying a portion of the nerve tissue of the target nerve. In some embodiments, such portions of the target nerve (e.g., GSN) that are destroyed (e.g., ablated) can regenerate. Thus, in some embodiments, a length of a portion of the target nerve to be destroyed can be specified or predetermined. In some embodiments, the durability of the effect for providing relief from a medical condition (e.g., heart failure) is related to the length of the nerve tissue of the destroyed target nerve. In some embodiments, the length of target nerve (GSN) destruction is an important factor for providing relief from heart failure symptoms, and destroying a longer length of the target nerve (e.g., via a vascular access mechanism and as compared to endovascular ablation) provides a longer period of removal of sympathetic nerve activity, thereby enabling the subject to experience relief from heart failure symptoms for a longer period. In some embodiments, vascular access (e.g., using the devices described herein) is configured to control the direction of the ablation modality. Thus, in some embodiments, the device is configured to target ablation of the target nerve to a particular portion and length of the corresponding nervous system. In some embodiments, the systems, methods, and devices described herein are configured to minimize collateral damage to other organs when ablating the target nerve. In some embodiments, collateral damage to other organs when ablating the target nerve is enabled through 1) positioning one or more ablation electrodes in proximity to or in contact with the target nerve, 2) delivering ablation energy via a bipolar configuration (thereby enabling control of the shape and distribution of the ablation energy (e.g., radiofrequency energy)), and / or 3) reducing the ablation energy requirements for interrupting the nerve activity of the target nerve. In some embodiments, the ablation energy (e.g., radiofrequency energy, microwave energy) delivered to the target nerve is from about 0.1 W to about 100 W. In some embodiments, the temperature provided for ablating the target nerve is from about -200°C to about 100°C.As described herein, in some embodiments, a needle assembly including two needles (e.g., two needle electrodes) is used to enable a plurality of electrodes to contact or be disposed proximate to a target nerve at two different locations, such that a length of the target nerve can be ablated as a result.

[0033] In some embodiments, the success of the methods described herein for treating a medical condition (e.g., heart failure) via nerve interruption is determined by nerve stimulation and detection of a physiological response (as described herein). In some embodiments, nerve sensing (e.g., measurement of the action potential of a target nerve) is also performed in combination with or instead of nerve stimulation. For example, in some embodiments, when a portion of a target nerve (e.g., the GSN) is destroyed (e.g., via ablation), the device is configured to provide nerve stimulation to confirm the absence of a sympathetic response. In some embodiments, providing nerve stimulation, as described herein, includes delivering charge (e.g., via a nerve stimulation component) through an electrode that is strong enough to induce a nerve reaction but not strong enough to damage tissue (nerve tissue or surrounding tissue). In some embodiments, the presence of a sympathetic response of the GSN is then monitored via a physiological response, for example, as described herein.

[0034] In some embodiments, after a portion of the target nerve has been destroyed (e.g., ablated), the physiological parameters are fixed and used as a baseline, and changes are detected after the target nerve has been stimulated (e.g., via the nerve stimulation components described herein) as an indicator of the sympathetic response. For example, as described herein, in some embodiments, the presence of a sympathetic response includes detecting an adverse change in the pulmonary capillary wedge pressure (PCWP) (e.g., an increase in PCWP), gastrointestinal changes including increased motility, changes in decreased sweating on the palm, abnormal changes in temperature for rectal and / or skin measurements, abnormal changes in renal output associated with changes in vasodilation, changes in metabolism (i.e., decreased glucose and glucagon release), and / or an increase in brain natriuretic peptide. In some embodiments, the nerve sensing component of the device detects the absence of nerve activity (e.g., by detecting any action potential), thereby indicating that the nerve has been successfully ablated (e.g., successfully lysed circumferentially). In some embodiments, detection of a decrease in PCWP (e.g., via the methods described herein) indicates that ablation has been successful when blood is diverted from the heart to the abdomen. In some embodiments, detection of a sympathetic response (e.g., the physiological responses described herein, or measurement of action potentials from the target nerve) indicates that the target portion of the target nerve has not been successfully destroyed (e.g., not ablated), and thus, treatment of the condition may be considered incomplete. In some embodiments, if it is determined that treatment is incomplete, the methods described herein (e.g., FIG. 1) are repeated to localize and destroy a portion of the target nerve as described herein.

[0035] Device As described herein, in some embodiments, the devices described herein are configured to treat a medical condition by interrupting neural activity of one or more target nerves. In some embodiments, the device is configured to destroy (e.g., via ablation) a portion of the nervous tissue of one or more target nerves. In some embodiments, the device is configured to target a specific portion of the target nerve for such destruction. In some embodiments, the device is configured to provide neural stimulation to the target nerve, sense neural activity from the target nerve, and / or ablate a portion of the target nerve.

[0036] In some embodiments, the device includes a catheter-based device. In some embodiments, the catheter-based device includes a device body configured to navigate within a subject. In some embodiments, the device body includes a radiopaque region (see, e.g., reference numeral 204 in FIG. 2). In some embodiments, the radiopaque region enables fluoroscopic guidance of the device within the subject. In some embodiments, the device body is operably communicative with a power source, a controller, an actuator, and / or a computing device to initiate operation of the device and / or to terminate or pause operation of the device. In some embodiments, the device is configured to be operably communicative with the power source via a cord (e.g., a cord plugged into the power source). In some embodiments, the device is configured to be operably communicative with the controller and / or actuator via a cord (e.g., a cord plugged into the power source). In some embodiments, the device is configured to be operably communicative with a computing device, a power source, a controller, and / or an actuator via a wireless component (e.g., Bluetooth®).

[0037] In some embodiments, a catheter-based device includes a vascular access mechanism, a mechanism for urging the catheter against the vein wall (within the subject), one or more ablation electrodes, one or more nerve stimulation electrodes, a nerve sensing region, or combinations thereof. In some embodiments, the vascular access mechanism comprises one or more needles or needle arrays of various sizes. In some embodiments, using the vascular access mechanism, the device is configured to position one or more ablation electrodes such that they contact or are disposed proximate to a target nerve. In some embodiments, the device uses one or more nerve stimulation electrodes to provide nerve stimulation to a target nerve. In some embodiments, the device is configured to sense the activity of a target nerve via a nerve sensing region. In some embodiments, the nerve sensing region includes one or more nerve sensing electrodes. In some embodiments, the nerve sensing region includes one or more sensors configured to sense nerve activity (such as action potentials). In some embodiments, the device is configured to ablate a portion of a target nerve using one or more ablation electrodes. In some embodiments, the ablation electrodes are configured to ablate at least a portion of a target nerve using high-frequency energy, microwave energy, or combinations thereof. In some embodiments, the device is configured to ablate a portion of a target nerve without ablation electrodes (e.g., chemical ablation, cryoablation, etc.).

[0038] In some embodiments, one or more ablation electrodes, one or more nerve stimulation electrodes, and one or more nerve sensing electrodes are provided as separate electrodes on the device. In some embodiments, one or more ablation electrodes, one or more nerve stimulation electrodes, one or more nerve sensing electrodes, or any combination thereof, include the same electrode. In some embodiments, the ablation electrodes, nerve stimulation electrodes, nerve sensing electrodes, or any combination thereof, include the same or different electrodes based on the placement and / or positioning of the device body within the subject (e.g., at the catheter tip).

[0039] Container puncture mechanism In some embodiments, as described herein, the device is configured to position a needle assembly (e.g., including a needle and an electrode) in contact with or in proximity to a target nerve (as described herein). In some embodiments, the device includes a vascular puncture mechanism (e.g., a venous puncture mechanism) configured to position a needle assembly that is configured to puncture a vein or an artery. In some embodiments, the needle assembly includes one or more needles (e.g., a needle electrode or a hollow needle as described herein) configured to puncture a vein or an artery. In some embodiments, the needle assembly includes an ablation electrode, a nerve sensory electrode, and / or a nerve stimulation electrode. In some embodiments, one or more ablation electrodes are disposed with the needle assembly. In some embodiments, the needle assembly is configured to extend from the device body of the device toward the target nerve.

[0040] In some embodiments, the needle assembly is configured to extend from within the device body of the device (e.g., a catheter-based device) toward the target nerve (e.g., see FIGS. 2-6). In some embodiments, the needle assembly is configured to extend through and penetrate the blood vessel wall (e.g., vein wall). In some embodiments, the needle assembly is configured to extend from the device body via a needle assembly push mechanism that can be actuated and / or moved from a location external to the subject (e.g., accessible by a user external to the subject). In some embodiments, the orientation in which the needle assembly extends through the blood vessel wall toward the target nerve can be adjusted by adjusting the orientation of the device body within the subject (e.g., rotating the device body). In some embodiments, radiopacity serves to enable rotational accuracy for positioning the needle assembly (as described herein). In some embodiments, the radiopaque marks appear different on the catheter body in 90-degree increments, thereby serving to orient the needle assembly in the up / down, front / back, outer / inner, and / or cranial / caudal directions. In some embodiments, the radiopaque appearance of the radiopaque marks under fluoroscopy changes as the device body rotates, which can serve to guide the device body and position the needle assembly. In some embodiments, the location on the device body where the needle assembly extends and / or the orientation in which the needle assembly extends correlates with the location of 1) the radiopaque marks, 2) one or more nerve stimulation electrodes, and / or 3) the nerve sensory region (e.g., nerve sensory electrodes, nerve sensors, etc.). In some embodiments, the device body has a longitudinal axis, and the needle assembly is configured to extend at a non-zero angle relative to the longitudinal axis.

[0041] In some embodiments, the needle assembly is disposed within the needle lumen in the device body or extends from the device body within a needle tube that is located external to it. In some embodiments, the needle tube is configured to extend until the end of the needle tube abuts or is disposed in proximity to a blood vessel wall (e.g., a vein wall). In some embodiments, the needle tube is configured to extend from the device body via a tube push mechanism (e.g., pushed by a user external to the subject) that can be actuated and / or moved from a location external to the subject. In some embodiments, the needle assembly is configured to extend through an opening at the end of the tube so as to pierce through the container wall. In some embodiments, the needle assembly is configured to extend from the tube via a needle assembly push mechanism that can be actuated and / or moved from a location external to the subject. In some embodiments, the orientation in which the needle assembly extends through the blood vessel wall towards the target nerve can be adjusted by adjusting the orientation of the device body within the subject (e.g., by rotating the device body).

[0042] In some embodiments, the device (e.g., a catheter-based device) is configured to provide a stepwise stimulation of the target nerve. For example, in some embodiments, the ablation electrode is the same electrode as the nerve stimulation electrode, the needle assembly is located within the needle tube, and the device is configured to stimulate the target nerve 1) when the needle tube and the needle assembly are disposed within the device body (i.e., before being deployed and extending from the device body) and 2) after the needle tube and the needle assembly have been deployed from the device body, and the needle tube abuts the blood vessel wall. Thus, in some embodiments, the device is configured to further confirm the location of the target nerve via stimulation provided from a closer location (e.g., at the blood vessel wall) prior to puncturing the blood vessel. In some embodiments, the stimulation is provided only at the blood vessel wall (i.e., not a stepwise stimulation).

[0043] In some embodiments, the device body includes one or more lumens (e.g., the needle lumen described herein) located therein. In some embodiments, the needle lumen extends within the device to an opening on the device body. In some embodiments, the opening is a lateral opening on the device body. In some embodiments, the needle lumen extends substantially parallel to the longitudinal axis of the catheter body. In some embodiments, the needle lumen curves so as to terminate at the lateral opening.

[0044] In some embodiments, the needle assembly is at least partially disposed on an outer portion of the device body. In some embodiments, the needle assembly is biased against a vessel wall (e.g., a vein wall) by a balloon such that the needle assembly is configured to pierce through the vessel wall and extend toward a target nerve (e.g., see FIGS. 7-20 as described herein). In some embodiments, the inflatable balloon is located around at least a portion of the outer surface of the device body of the device (e.g., a catheter-based device) described herein. In some embodiments, the needle assembly is disposed on the device body such that inflating (or expanding) the balloon moves the needle assembly and biases it toward the vessel wall. In some embodiments, the needle assembly is biased toward the vessel wall but does not pierce the vessel wall. In some embodiments, the needle assembly is biased toward the vessel wall and is pierced through the vessel. In some embodiments, the balloon is inflated or expanded via methods known in the art, such as by providing an inflation medium via an inflation tube in fluid communication with the inflatable balloon. In some embodiments, the inflation medium includes air, another gas, a liquid, saline, or other fluids known in the art. In some embodiments, the inflation medium is provided by a source located external to the subject. In some embodiments, the needle assembly is configured to extend toward a target nerve through a needle assembly push mechanism that can be actuated and / or moved from a location external to the subject through the vessel wall. In some embodiments, the orientation in which the needle assembly extends through the vessel wall toward the target nerve can be adjusted by adjusting the orientation of the device body within the subject (e.g., by rotating the device body).

[0045] In some embodiments, the device body includes one or more lumens located therein. In some embodiments, the inflation tube is located within an inflation lumen within the device body. In some embodiments, the inflation lumen extends within the device and enables fluid communication between the inflatable balloon and the inflation tube.

[0046] Needle assembly In some embodiments, as described herein, a needle assembly (including any vascular access mechanism) for any of the devices described herein (e.g., a catheter-based device) comprises one or more needle electrodes (see, for example, FIGS. 4 and 9). In some embodiments, each needle electrode includes a needle stem and one or more electrodes. In some embodiments, the needle stem and one or more electrodes for each needle electrode are integrated together as a single component. In some embodiments, the needle stem and one or more electrodes are coupled together for each needle electrode that can be a removable coupling. In some embodiments, the one or more electrodes for each needle electrode include one or more ablation electrodes. In some embodiments, the one or more electrodes for each needle electrode include one or more ablation electrodes, one or more nerve stimulation electrodes, and / or one or more nerve sensing electrodes. In some embodiments, the one or more electrodes are disposed at any location on each needle electrode. In some embodiments, at least one electrode is located on the distal end of the needle electrode, the distal end of the needle electrode stem is in contact with or proximate to a target nerve (e.g., the GSN), and the proximal end of the needle electrode is in contact with, within, and / or proximate to the device body of the device. In some embodiments, at least one needle electrode includes a single electrode. In some embodiments, at least one needle electrode includes a plurality of electrodes. In some embodiments, the plurality of electrodes includes an electrode array. In some embodiments, the electrode array is arranged in a linear configuration. In some embodiments, the electrode array includes a plurality of electrodes that are spaced apart from and / or electrically isolated from each other. As described herein, in some embodiments, a plurality of electrodes (e.g., ablation electrodes) are configured to provide ablation energy in a bipolar-like manner.

[0047] In some embodiments where the needle assembly includes two or more needle electrodes, the needle electrodes are configured to be constrained and / or compressed towards each other in a pre-deployed configuration (e.g., when the needle assembly is located within the device body, within the needle cannula, before being biased against the vessel wall, before puncturing through the vessel wall, or any combination thereof). For example, in some embodiments, two or more needle electrodes are configured to be constrained and / or compressed towards each other when moving to a desired location near a target nerve (e.g., the GSN) using the device body. In some embodiments, two or more needle electrodes remain constrained and / or compressed towards each other in a pre-deployed configuration (e.g., a non-bifurcated configuration as described herein). In some embodiments, the needle assembly is held in a pre-deployed configuration by a needle assembly tube (as described herein), and the needle assembly is positioned therein (e.g., the inner wall of the needle assembly tube constrains the needle assembly from bifurcating). In some embodiments, two or more needle electrodes are configured to separate from each other at the distal end when the needle assembly extends a predetermined length from the device body. For example, in some embodiments, the needle assembly includes two needles configured to bifurcate at the distal end of the needle assembly (see, e.g., FIGS. 3 and 4 and FIGS. 8 and 9), thereby allowing the needle assembly to contact or be disposed in proximity to the target nerve at two different locations of the two bifurcated distal ends of the needle electrodes. Thus, in some embodiments, the needle assembly is configured to target ablation at two or more locations of the target nerve (e.g., via high-frequency or microwave energy using the needle electrodes), thereby allowing ablation of a length of the target nerve between and / or around the two or more locations. In some embodiments, the ability of the needle electrodes to bifurcate allows for changing the shape of the thermal zone along the length of the target nerve, resulting in the intended benefit of longevity.

[0048] In some embodiments, the distance between the tips of two needles (e.g., needle electrodes) for a needle assembly in a bifurcated configuration is identified as the deployed distance. As used herein, in some examples, the term "bifurcated configuration" is used interchangeably with the term "bifurcated position". In some embodiments, the deployed distance is from about 1 mm to about 10 cm. In some embodiments, the distance between the tips of two needles (e.g., needle electrodes) for a needle assembly in a non-bifurcated configuration (as described herein) is identified as the non-bifurcated distance. In some embodiments, the deployed distance is greater than the non-bifurcated distance. In some embodiments, the non-bifurcated distance is zero (e.g., 0 mm) or substantially zero. In some embodiments, as described herein, the device is configured to ablate a target nerve that is at least the length of the deployed distance.

[0049] As described herein, in some embodiments, ablation of the target nerve includes a complete circumferential ablation of the target nerve along a given length. In some embodiments, the needle electrodes are configured to separate (e.g., bifurcate) from each other at the distal end of the needle assembly by a predetermined length. In some embodiments, the needle electrodes are configured to separate (e.g., bifurcate) from each other in a predetermined orientation such that the separation (e.g., bifurcation) of the needle electrodes (e.g., the deployed distance) is aligned with the length of the target nerve. For example, in some examples, the target nerve (e.g., the GSN) runs perpendicular to the vein described herein, such that the needle electrodes separate along the axis of the target nerve when piercing through and / or after piercing through the vein wall. In some examples, the target nerve runs parallel to the vein such that the needle electrodes separate along a direction parallel to the target nerve. In some embodiments, each needle electrode of the needle assembly is electrically isolated from each other. In some embodiments, the needle assembly is configured to deliver energy in a bipolar fashion. In some embodiments, for example, with respect to a bifurcated needle assembly, high-frequency energy is configured to be delivered through both needle electrodes in a bipolar fashion such that a longer length of nerve can be destroyed (e.g., as compared to ablation from within a blood vessel).

[0050] In some embodiments, the needle assembly comprises three needles, and the needle assembly is configured to move from a pre - deployed configuration (as described herein) to a configuration in which the tips of the three needles are spaced apart from each other. In some embodiments, the needles are configured to be spaced apart from each other in any direction (e.g., three - dimensionally), thereby being configured to target three locations on the target nerve for ablation.

[0051] In some embodiments, the needle assembly comprises one or more needle electrodes having an electrode array disposed thereon. In some embodiments, the electrode array includes a plurality of electrodes. In some embodiments, the plurality of electrodes are electrically isolated from each other. In some embodiments, the electrode array is disposed in a linear configuration on the same side of the needle electrode. In some embodiments, the device is configured to introduce a linear electrode array that moves in one direction along the length of the nerve after venipuncture. The electrode array creates a plurality of small thermal zones to ablate a long section of the nerve. This enables higher accuracy and length of nerve ablation. In an exemplary embodiment, the linear electrode array can be used from within a vein, artery, or blood vessel (e.g., the main junction vein) that can move parallel to the target nerve (e.g., the visceral nerve), and the linear electrode array is configured to create a plurality of small thermal zones to ablate a long section of the nerve. This enables higher accuracy and length of nerve ablation. In some embodiments, a linear electrode array positioned within the target nerve is also configured to stimulate the target nerve.

[0052] In some embodiments, the electrode array is arranged to be spaced apart from each other such that (e.g., after the needle electrode is punctured through the blood vessel wall) each electrode targets ablation at a corresponding location on the target nerve. Thus, in some embodiments, the needle electrode is configured to target ablation of a length of the target nerve corresponding to at least the length of the electrode array disposed on the needle electrode. In some embodiments, the plurality of electrodes are disposed on one side of the needle electrode to differentially vary the thermal map of the ablation zone, and as a result, are specifically directed to the target nerve.

[0053] In some embodiments, each needle electrode is operably communicative with a power source (such as described herein). In some embodiments, the same power source is configured to deliver power to each needle electrode. In some embodiments, two or more power sources are configured to deliver power to a plurality of needle electrodes. In some embodiments, the power source is located external to the subject. In some embodiments, the power source includes a controller for regulating the power delivered to the electrodes on the needle assembly. In some embodiments, the power source is operably communicative with the controller for regulating the power delivered to the electrodes. In some embodiments, the controller is located on and / or within the device body. In some embodiments, the controller includes a computing device. In some embodiments, the power supplied to each needle electrode of the needle assembly is sufficient to ablate a portion of the target nerve. As described herein, in some embodiments, the power supplied to each needle electrode radiates radio frequency energy (e.g.) that generates heat, which results in ablation of a portion of the target nerve. In some embodiments, the power source and the controller are configured to regulate the power delivered to the device to vary the amount of radio frequency energy delivered by each needle electrode. In some embodiments, the power source is provided with the device itself (e.g., a battery located within or around the device body) alternately with, or in combination with, an external power source. In some embodiments where the power source is provided with the device, the user can regulate the power delivered to and by each needle electrode via an external adjustment controller that is operably communicative with the device.

[0054] In some embodiments, the device is configured to deliver a chemical substance to a target nerve so as to chemically ablate the target nerve. In some embodiments, the device is configured to deliver a controlled amount of fluid to and / or around the target nerve to interrupt the nerve activity of the target nerve. In some embodiments, the fluid comprises a chemical substance. In some embodiments, the fluid comprises one or more fluids. In some embodiments, the one or more fluids are gaseous and / or liquid. In some embodiments, the fluid comprises carbon dioxide, ethanol, liquid nitrogen, a conductive substance (e.g., saline, a special hydrogel, etc.), alcohol, lidocaine, a lidocaine analog, or a combination thereof. In some embodiments, the needle assembly comprises one or more hollow needles (see, e.g., FIG. 15). In some embodiments, each hollow needle includes an opening disposed at any location on the hollow needle. In some embodiments, each hollow needle is configured to dispense a fluid (e.g., a chemical substance) through the opening. In some embodiments, each hollow needle is configured to facilitate chemical ablation of a portion of the target nerve by dispensing the fluid onto and / or around the target nerve. In some embodiments, the fluid to be delivered is stored within the hollow needle prior to deployment of the hollow needle. In some embodiments, each hollow needle is in fluid communication with a fluid source. In some embodiments, each hollow needle is configured to dispense the fluid in a controlled manner so as to chemically ablate a predetermined or minimal portion of the target nerve.

[0055] In some embodiments, the device is configured to lower the temperature of the target nerve and / or the temperature around the target nerve so as to generate ice globules in the target nerve as a function of cryotherapy ablation. In some embodiments, the needle assembly comprises a hollow needle for forming ice globules for destroying a portion of the target nerve tissue as described herein. In some embodiments, the hollow needle is configured to dispense a cold fluid to and / or around the target nerve, thereby enabling destruction of a portion of the target nerve.

[0056] In some embodiments, a needle assembly including a hollow needle is configured to separate at a distal end as described herein for the needle electrodes so as to target chemical ablation and / or cryoablation at a particular location of a target nerve, thereby enabling a longer ablation length of the target nerve.

[0057] In some embodiments, the device is configured to operate other types of ablation modalities such as ultrasonic ablation and / or alcohol ablation (in addition to, or alternatively to, high-frequency ablation, microwave ablation, chemical ablation, and / or cryoablation).

[0058] Nerve Stimulation and Nerve Sensation In some embodiments, as described herein, the device is configured to stimulate a target nerve and / or to sense activity by the target nerve. In some embodiments, the device includes one or more nerve stimulation electrodes for stimulating the target nerve. In some embodiments, the device includes a nerve sensing region configured to sense the target nerve. In some embodiments, the one or more nerve stimulation electrodes and the one or more nerve sensing regions are located on the device body of the device. In some embodiments, the nerve sensing region, the one or more nerve stimulation electrodes, and / or the one or more ablation electrodes are located at any location on the device body of the device (e.g., a catheter). In some embodiments, the nerve sensing region includes a sensor for detecting action potentials from the target nerve. In some embodiments, the nerve sensing region includes one or more nerve sensing electrodes for detecting action potentials from the target nerve. In some embodiments, the one or more nerve sensing electrodes and the one or more nerve stimulation electrodes include different electrodes. In some embodiments, the one or more nerve sensing electrodes and the one or more nerve stimulation electrodes share the same electrodes. In some embodiments, the one or more nerve stimulation electrodes are configured to provide stimulation to the target nerve in a monopolar mode. In some embodiments, the one or more nerve stimulation electrodes are configured to provide stimulation to the target nerve in a bipolar mode.

[0059] In some embodiments, as described herein, the device is configured to alternate between a neuro-sensory mode (e.g., sensing the action potential of a target nerve) and a nerve stimulation mode (e.g., providing a stimulus to the target nerve). Instead of, or in addition to, alternating the operating modes of the device, in some embodiments, the device is configured to operate the neuro-sensory mode and the nerve stimulation mode simultaneously.

[0060] As described herein, in some embodiments, the nerve stimulation mode includes one or more nerve stimulation electrodes configured to stimulate a target nerve to induce nerve activity (e.g., nerve action potential) and / or a physiological change (e.g., sympathetic response). As described herein, in some embodiments, one or more physiological monitoring devices are provided for measuring, sensing, and / or detecting nerve activity and / or physiological changes (e.g., sympathetic response) based on stimulation of the target nerve (as described herein). For example, as described herein, in some embodiments, the one or more physiological monitoring devices include a Swan-Ganz catheter for PCWP measurement. In some embodiments, the one or more physiological monitoring devices are configured to read and interpret physiological signals related to gastrointestinal changes, sweating of the palm, PCWP, rectal and / or skin measurement temperature, changes in vasodilation, renal output related to metabolic changes, and / or serum brain natriuretic peptide levels in real-time or substantially in real-time during the methods described herein. In some embodiments, based on the measured physiological readings, a user (e.g., a physician or other healthcare provider) can provide and / or adjust nerve stimulation via the device to stimulate the target nerve and thereby induce a desired effect (e.g., an increase in sympathetic action on the abdominal vasculature). In some embodiments, by making the following changes, a user (e.g., a physician or other healthcare provider) can read and interpret the corresponding physiological signals, thereby confirming that the device (e.g., a catheter-based device) is in the correct location. That is, detection of gastrointestinal changes including decreased motility, detection of increased sweating of the palm, detection of increased PCWP, changes in rectal and / or skin measurement temperature, changes in renal output related to changes in vasodilation, changes in metabolism (e.g., increased glucose and glucagon release), and / or detection of increased brain natriuretic peptide is confirmed. In some embodiments, based on the absence of sufficient physiological changes as detected via any combination of the physiological signals, the user can then reposition the device within the subject to approach the location of the target nerve again and provide stimulation again to detect physiological changes.

[0061] In some embodiments, one or more physiological monitoring devices operably communicate with a computing device and / or a display to output measured physiological readings and / or changes. In some embodiments, at least one physiological monitoring device is integrated with a catheter-based device as described herein.

[0062] In some embodiments, after a nerve ablation is performed, a device (e.g., a catheter-based device) is used to stimulate the nerve again (as described herein). In some embodiments, the ablated portion of the target nerve results in a lack of physiological change when stimulated (e.g., via a nerve stimulation component as described herein). In some embodiments, after a portion of the target nerve has been ablated (e.g., ablated), the following physiological parameters are fixed and used as a baseline for detecting changes after applying a stimulus to the target nerve (e.g., via a nerve stimulation component as described herein). Detecting gastrointestinal changes including increased motility, detecting changes in decreased sweating on the palm of the hand, detecting a decrease in PCWP, changes in temperature of rectal and / or skin measurements, changes in renal output related to changes in vasodilation, changes in metabolism, a decrease in glucose and glucagon release, etc., and / or detecting a decrease in brain natriuretic peptide. In some embodiments, detecting a decrease in PCWP is an indicator of GSN activity interruption because it suggests that blood is being drawn from the heart.

[0063] In some embodiments, one or more nerve sensory electrodes are configured to detect action potentials from a target nerve. In some embodiments, one or more nerve sensory electrodes are configured to output detection of the action potential to a user via an external device, a computing device, or other mechanism known in the art.

[0064] Power and Control As described herein, in some embodiments, a device described herein (e.g., a catheter-based device) is operably communicable with a power source and receives power therefrom. In some embodiments, the power source (e.g., a generator) is configured to regulate the power delivered to the device. In some embodiments, the power source is configured to: 1) provide nerve stimulation energy to nerve stimulation electrodes, 2) provide ablation energy to ablation electrodes, and / or 3) enable the device to detect, read, and / or interpret nerve signals via a nerve sensing region (e.g., via a sensor or nerve sensing electrode). In some embodiments, the power source comprises a controller and / or communicates with a controller configured to regulate the power supplied to the device. In some embodiments, the controller comprises a computing device and / or a display for outputting information. In some embodiments, separate power sources and / or controllers are configured to provide power to each of the ablation electrodes, nerve stimulation electrodes, and / or nerve sensing regions.

[0065] In some embodiments, the power source (e.g., a generator) is configured to provide high-frequency energy to generate a thermal ablation zone in nerve tissue. In some embodiments, the thermal ablation zone receives heat generated by high-frequency energy provided, for example, by one or more ablation electrodes. In some embodiments, providing high-frequency energy includes an alternating current (e.g., in the range of 350 - 500 kHz). In some embodiments, the device is configured to destroy at least a portion of the target nerve and venous tissue (e.g., via a generator and / or electrodes located on the device that pierce the vein wall and contact or are disposed proximate to the target nerve). In some embodiments, the device is configured to provide high-frequency energy for stimulating a target nerve or group of nerves without damaging the nerve tissue of the target nerve and / or surrounding tissue.

[0066] In some embodiments, a device (e.g., a catheter-based device) and / or a power source (e.g., a generator) are configured to adjust voltage and current outputs according to a desired power of ablation energy (e.g., radiofrequency energy, microwave energy) delivered to a target nerve (via an ablation electrode). In some embodiments, the power source is operably communicable with a controller to adjust voltage and current outputs. In some embodiments, the device includes a controller located therein (e.g., within and / or on the device body). In some embodiments, the ablation energy is provided with a voltage and current sufficient to generate enough heat (transmitted to the target nerve) to destroy at least a portion of the target nerve. In some embodiments, the power source is configured to provide from about 1 W to about 100 W of power to the device. In some embodiments, at least a portion of the target nerve is destroyed circumferentially around the target nerve (as described herein). In some embodiments, the device and / or power source are further configured to adjust the power of ablation energy (e.g., radiofrequency energy, microwave energy) delivered to cause destruction of venous tissue and induce vascular sclerosis such that the devices described herein are further configured to reduce, prevent, and / or stop bleeding. In some embodiments, such destruction of venous tissue and vascular sclerosis is via an ablation electrode and / or another set of electrodes.

[0067] In some embodiments, the power source is configured to deliver a charge that is strong enough to induce a nerve response (e.g., via a nerve stimulation electrode) but not strong enough to damage tissue (e.g., target nerve tissue and / or surrounding tissue). In some embodiments, a controller as described herein is configured to adjust the charge delivered by the nerve stimulation electrode.

[0068] In some embodiments, the power source receives power from the outer wall unit. Alternatively, or additionally, in some embodiments, the power source (e.g., a generator) includes one or more power sources (e.g., batteries) located therein.

[0069] Figures 2-27B depict exemplary embodiments of devices (e.g., catheter-based devices) described herein and for use in the methods described herein. In some embodiments, any of such exemplary device embodiments include any combination of the features and components described above for the devices described herein.

[0070] Figures 2-6 provide exemplary depictions of a first embodiment of the device 200 described herein, and a needle assembly comprising two needle electrodes is used to ablate a portion of a target nerve. In some embodiments, referring to FIG. 2, the device includes a device body (e.g., a catheter body) 210, a catheter tip 202, a needle assembly 206 configured to be disposed within the catheter body, an opening 208 through which the needle assembly 206 extends, and an electrode region 207 (e.g., for nerve stimulation). In some embodiments, the opening 208 is a lateral opening. In some embodiments, the device body 210 has a longitudinal axis (203). In some embodiments, the electrode region may also be located at any location on the catheter body 210 and in the same location as a nerve sensing region as described herein (e.g., for measuring action potentials). In some embodiments, the electrode region 207 is provided on the catheter body 210. In some embodiments, the device includes a radiopaque region 204 that can be used to assist in tracking the location of the device within a subject. In some embodiments, the radiopaque region is located at any location on the catheter body. In some embodiments, the radiopacity serves to enable rotational accuracy for positioning the needle assembly (as described herein). In some embodiments, the radiopaque marks appear different on the catheter body in 90-degree increments, thereby serving to orient the needle assembly in the up / down, front / back, outer / inner, and / or cranial / caudal directions.

[0071] Referring to FIGS. 3 and 4, an exemplary depiction of a needle assembly 206 protruding from (e.g., deployed) an opening 208 of device 200 is shown. In some embodiments, the device body 210 includes a needle lumen that extends within the device body and terminates at a lateral opening 208. In some embodiments, the needle assembly is positioned within the needle lumen. In some embodiments, the needle assembly includes two needle electrodes, each having a separate needle stem 214, 215. In some embodiments, each needle electrode includes an electrode 212, 213 corresponding to the distal end of the needle assembly. In some embodiments, the electrodes are configured to be located at any location on each needle electrode. As described herein, in some embodiments, each electrode 212, 213 is an ablation electrode configured to provide high-frequency energy or microwave energy to ablate at least a portion of a target nerve. In some embodiments, electrodes 212, 213 are configured to act as nerve stimulation electrodes and / or nerve sensing electrodes. In some embodiments, the needle assembly 206 is disposed within the catheter body in a compressed configuration such that the needle stems 214, 215 and in some instances the electrodes 212, 213 are pushed together. In some embodiments, the needle assembly 206 is configured to bifurcate as it exits the opening 208, and at least a portion of the electrodes 212, 213 of the corresponding needle electrodes and the needle stems 214, 215 are configured to separate from each other (e.g., separate in a "V" shape) as they extend from the opening 208. In some embodiments, the needle assembly includes a shape memory portion such that it is configured to bifurcate as it exits the opening 208 and enters an open space. In some embodiments, the needle assembly 206 is configured to bifurcate based on an actuation mechanism. In some embodiments, the actuation mechanism includes automatic and / or manual actuation (e.g., actuation by a user). In some embodiments, the needle assembly 206 bifurcates along the length of the target nerve or at approximately a certain length, thereby enabling each electrode 212, 213 to contact or be disposed in proximity to two different locations on the target nerve.

[0072] As described herein, in some embodiments, a needle assembly push stem (or other structure) is provided within catheter body 210 and configured to engage the needle assembly to push the needle assembly 206 through opening 208. In some embodiments, the push stem is located within catheter body 210 and configured to operate to automatically eject needle assembly 206 from opening 208. In some embodiments, the automatic operation of the push stem is initiated by a wireless or wired signal provided by the user. In some embodiments, the push stem is configured to be manually ejected by the user (via a mechanism extending from the device to the outside of the subject). In some embodiments, the needle assembly, e.g., electrodes 212, 213, is configured to extend a predetermined distance from the opening such that it pierces through the vein wall and contacts or is positioned proximate to a target nerve (e.g., a GSN as described herein).

[0073] In some embodiments, as described herein, needle assembly 206 is provided within a needle assembly tube (not shown) located within catheter body 210. In some embodiments, the tube is configured to extend from opening 208 to the vein wall, and the needle assembly is then configured to extend from the end of the tube and pierce through the vein wall. In some embodiments, the needle assembly tube is similar to the tube shown in FIGS. 7-11 by reference numeral 309.

[0074] In some embodiments, catheter body 210 is configured to rotate to orient the needle assembly in a predetermined direction relative to the target nerve. In some embodiments, the needle assembly is configured to extend from the catheter body according to a particular configuration, which corresponds to the location of a radiopaque marker (e.g., 204) such that the direction and position of the electrodes on the needle assembly during expansion can be correlated with the location of the radiopaque marker.

[0075] FIG. 5 and FIG. 6 show an exemplary depiction of device 200 located within a vein, artery, or blood vessel 218 (e.g., left and / or right anorectal venous branch 2204 of FIG. 22), and needle assembly 206 extends from opening 208 and contacts a target nerve (e.g., GSN) in a bifurcated configuration at two different locations between two portions of target nerves 220, 221 (see FIG. 6). As described herein, in some embodiments, needle assembly 206 bifurcates along the length of the target nerve. As described herein, catheter body 210 is configured to be rotatable to position bifurcated needle stems 214, 215 along the length of the target nerve. In some embodiments, the needle assembly extends at a non-zero angle relative to the longitudinal axis 203. For example, in FIG. 6, catheter body 210 is characterized as being positioned along the x-axis, and needle stems 214, 215 bifurcate along the z-axis corresponding to the length of the target nerve between two locations 220, 221. Thus, electrodes 212, 213 are configured to ablate (e.g., circumferentially dissolve) a length of the target nerve that is at least the length from target nerve location 220 to target nerve location 221. In some embodiments, around target nerves 220, 221 represents an ablation zone (at a given location), and the portion of the target nerve between portion 220 and portion 221 represents the length of the ablation zone. In some embodiments, as described herein, the longer the length of the ablation zone, the longer the treatment period for the medical conditions (e.g., heart failure) described herein is provided.

[0076] In some embodiments, the electrode region 207 is configured to provide stimulation to a target nerve (e.g., via a nerve stimulation electrode as described herein). In some embodiments, the electrode region is positioned within the subject at a location corresponding to the target nerve (e.g., the location can be such that nerve stimulation is provided to the target nerve perpendicular to the axis of the catheter body 210) (e.g., via a radiopaque marker and / or a nerve perception region). Thus, in some embodiments, the stimulation is provided via a signal delivered perpendicularly. In some embodiments, the configuration of the needle assembly extending from the catheter body correlates with the positioning of the electrode region 207.

[0077] Figures 7-13 provide exemplary depictions of a second embodiment of the device 300 described herein, where a needle assembly including two needle electrodes is used with a balloon to ablate a target nerve. In some embodiments, the balloon is configured to inflate. In some embodiments, referring to FIG. 7, the device includes a device body (e.g., a catheter body) 310, a catheter tip 302, a needle assembly 306 configured to be disposed with a balloon positioned around the catheter body 310, and an electrode region 307 (e.g., for nerve stimulation). In some embodiments, the device body 310 has a longitudinal axis (303). In some embodiments, the electrode region may also be located at any location on the catheter body 310, in the same location as the nerve sensory region described herein. In some embodiments, the electrode region 307 is disposed on the balloon 308. In some embodiments, the device 300 further includes a needle assembly tube 309 configured such that at least a portion of the needle assembly 306 is located therein and further configured to extend therefrom. In some embodiments, the needle assembly tube 309 is embedded in and protrudes from the balloon 308. In some embodiments, the device 300 does not include a needle assembly tube and, instead, the needle assembly 306 is located on, at least partially within, or a combination of the balloon 308. In some embodiments, the needle assembly tube is at least partially located within the device body 310. In some embodiments, the device includes a radiopaque region 304 that can be used to assist in tracking the location of the device within a subject. In some embodiments, the radiopaque region is located at any location on the catheter body. In some embodiments, the radiopacity helps to enable rotational accuracy for positioning the needle assembly (as described herein). In some embodiments, the radiopaque marks appear different on the catheter body in 90-degree increments, thereby assisting in orienting the needle assembly in the up / down, front / back, outer / inner, and / or cranial / caudal directions.

[0078] Referring to FIGS. 8 and 9, an exemplary depiction of the needle assembly 306 of the device 300 is shown. In some embodiments, the needle assembly 306 comprises two separate needle electrodes, each having a needle stem 314, 315. In some embodiments, each needle electrode includes electrodes 312, 313 corresponding to the distal end of the needle assembly. In some embodiments, the electrodes are configured to be located at any location on each needle electrode. As described herein, in some embodiments, each of the electrodes 312, 313 is an ablation electrode configured to provide high-frequency energy to ablate at least a portion of the target nerve. In some embodiments, the electrodes 312, 313 are configured to act as nerve stimulation electrodes and / or nerve sensing electrodes. In some embodiments, at least a portion of the needle assembly 306 is located within the needle assembly lumen 309 when the device is advancing to a desired location within the subject. In some embodiments, the needle assembly 306 is configured to extend from the needle assembly tube 309. In some embodiments, the needle assembly 306 is configured to be provided in a compressed configuration such that the needle stems 314, 315, and in some instances, the electrodes 312, 313 are pushed together. In some embodiments, the needle assembly 306 is configured to bifurcate when extending from the needle assembly lumen 309, and at least a portion of the electrodes 312, 313 and the needle stems 314, 315 of the needle electrodes are configured to separate from each other (e.g., the needle assembly includes a "V-shaped" configuration). In some embodiments, the needle assembly 306 includes a shape memory portion such that it is configured to bifurcate when extending a predetermined length from the needle assembly tube 309. In some embodiments, the needle assembly 306 is configured to bifurcate based on an actuation mechanism. In some embodiments, the actuation mechanism includes automatic and / or manual actuation (e.g., actuation by a user). In some embodiments, the actuation mechanism includes automatic and / or manual actuation. In some embodiments, the needle assembly 306 bifurcates along the length of the target nerve, thereby enabling each of the electrodes 312, 313 to contact or be disposed in proximity to two different locations on the target nerve.

[0079] Figures 10 and 11 show exemplary depictions of device 300 located within a vein, artery, or blood vessel 316 (e.g., left and / or right inter-anal vein bifurcation 2204 of FIG. 22) and proximal to the location of target nerve 318. FIG. 10 shows balloon 308 in a contracted configuration and prior to deployment of needle assembly 306, while FIG. 11 shows balloon 308 in an expanded configuration. In some embodiments, needle assembly 306 is positioned such that expanding balloon 308 pushes out needle assembly tube 309, thereby enabling needle assembly 306 to pierce through the wall of vein 316 (see FIG. 11). In some embodiments, expanding balloon 308 biases needle assembly tube 309 against the container wall such that needle assembly 306 is configured to pierce through the container wall as it extends from the needle assembly tube. In some embodiments, expanding balloon 308 biases needle assembly tube 309 against the container wall, but needle assembly 306 does not yet pierce the container wall unless it extends from the needle assembly tube. In alternative embodiments, the needle assembly is configured to bias against the container wall through means other than an inflatable balloon (known in the art).

[0080] In some embodiments, balloon 308 is in fluid communication with an inflation medium that enables inflation of the balloon. In some embodiments, device body 310 includes an inflation tube that extends therein and is in fluid communication with an inflation medium source. In some embodiments, the inflation medium includes a fluid such as a gas (e.g., air, etc.) and / or a liquid (e.g., water, saline, etc.). In some embodiments, the inflation medium source is located outside of the subject. In some embodiments, the device includes a stored supply of inflation medium for inflating balloon 308. In some embodiments, the inflation medium is supplied via an automatic controller. In some embodiments, the inflation medium is supplied via manual input.

[0081] Figures 12 and 13 show exemplary embodiments of a needle assembly 306 extending toward a target nerve 318. In some embodiments, balloon inflation enables the needle assembly 306 to extend toward the target nerve. As described herein, in some embodiments, a needle assembly push system (or other structure) is provided within the catheter body 310 and is configured to engage and push the needle assembly 306 through the vessel wall and / or toward the target nerve. In some embodiments, the push system is located within the catheter body 310 and is configured to actuate to automatically push the needle assembly 306. In some embodiments, the automatic actuation of the push system is initiated by a wireless or wired signal provided by the user. In some embodiments, the push system is configured to be manually pushed by the user (via a mechanism extending outside the subject from the device). In some embodiments, the needle assembly 306, e.g., electrodes 312, 313, is configured to extend a predetermined distance from the needle assembly lumen such that it contacts or is located in proximity to the target nerve 318 (e.g., a GSN as described herein).

[0082] In some embodiments, the catheter body 310 is configured to rotate to orient the needle assembly 306 in a predetermined direction with respect to the target nerve. In some embodiments, the needle assembly is configured to extend from the catheter body according to a particular configuration, which corresponds to the location of a radiopaque marker (e.g., 304) such that the direction and position of the electrodes on the needle assembly upon expansion can be correlated with the location of the radiopaque marker.

[0083] FIG. 13 shows an exemplary depiction of a needle assembly 306 that extends to and contacts a target nerve (e.g., GSN) in a bifurcated configuration at two different locations between two portions of the target nerves 318, 319. As described herein, in some embodiments, the needle assembly 306 bifurcates along the length of the target nerve. In some embodiments, the needle assembly 306 extends at a non-zero angle with respect to the longitudinal axis 303. As described herein, the needle assembly 306 is configured to be rotatable about the needle assembly axis such that the bifurcated needle stems 314, 315 of the needle electrodes are positioned along the length of the target nerve. For example, in FIG. 13, the catheter body 310 is characterized as being positioned along the x-axis, and the needle stems 314, 315 bifurcate along the z-axis corresponding to the length of the target nerve between the two locations 318, 319. Thus, the electrodes 312, 313 are configured to ablate (e.g., circumferentially dissolve) a certain length of the target nerve, which is at least the length from the target nerve location 318 to the target nerve location 319. In some embodiments, the areas 318, 319 around the target nerve represent the ablation area at a given location, and the portion of the target nerve between the portion 318 and the portion 319 represents the length of the ablation area. In some embodiments, as described herein, the longer the length of the ablation area, the longer the treatment period for the medical conditions (e.g., heart failure) described herein is provided.

[0084] In some embodiments, the electrode region area 307 is configured to provide stimulation to the target nerve (e.g., via the nerve stimulation electrodes described herein). In some embodiments, the electrode region is positioned within the subject at a location corresponding to the target nerve (e.g., the location may be such that nerve stimulation is provided to the target nerve perpendicular to the axis of the catheter body 310) (e.g., for use with a radiopaque marker and / or a nerve perception area). Thus, in some embodiments, the stimulation is provided via a signal delivered perpendicularly. In some embodiments, the configuration of the needle assembly extending from the catheter body correlates with the positioning of the electrode region 307.

[0085] Figures 14-17 provide exemplary depictions of a third embodiment of the device 400 described herein, the device being configured to chemically ablate a target nerve. In some embodiments, referring to FIG. 14, the device includes a device body (catheter body) 410, a catheter tip 402, a needle assembly 406 configured to be disposed with an expandable balloon 408 positioned around the catheter body 410, and an electrode region 407 (e.g., for nerve stimulation). In some embodiments, the device body 410 has a longitudinal axis (403). In some embodiments, the electrode region may also be located at any location on the catheter body 410, in the same location as the nerve sensory region described herein. In some embodiments, the electrode region 407 is disposed on the expandable balloon 408. In some embodiments, the device 400 further includes a needle assembly tube 409, configured such that at least a portion of the needle assembly 406 is positioned therein and further configured to extend therefrom. In some embodiments, the needle assembly tube 409 is embedded in and protrudes from the expandable balloon 408. In some embodiments, the device includes a radiopaque region 404 that can be used to assist in tracking the location of the device within the subject. In some embodiments, the radiopaque region is located at any location on the catheter body. In some embodiments, the radiopacity serves to enable rotational accuracy for positioning the needle assembly (as described herein). In some embodiments, the radiopaque marks appear different on the catheter body in 90-degree increments, thereby assisting in orienting the needle assembly in the up / down, front / back, outside / inside, and / or cranial / caudal directions.

[0086] Referring to FIG. 15, an exemplary depiction of the needle assembly 406 of device 400 is shown. In some embodiments, the needle assembly comprises a needle stem 414 and a needle port 412. In some embodiments, the needle stem is hollow. In some embodiments, the device is configured to dispense a chemical substance through the needle port 412. In some embodiments, the chemical substance is configured to ablate a target nerve. In some embodiments, the device is configured to dispense the chemical substance in a controlled distribution to achieve a desired ablation length of the target nerve. In some embodiments, at least a portion of the needle assembly 406 is located within the needle assembly lumen 409 when the device is advancing to a desired location within the subject. In some embodiments, the needle assembly 406 is configured to extend from the needle assembly lumen 409.

[0087] FIGS. 16 and 17 show exemplary depictions of device 400 located within a vein, artery, or blood vessel 416 (e.g., the left and / or right intersphincteric venous branch 2204 of FIG. 22) and proximal to the location of the target nerve 418. FIG. 16 provides an exemplary depiction of the expandable balloon 408 in an expanded configuration, where the needle assembly tube 409 is biased toward the vein wall 416 such that the needle assembly 406 punctures through the vein wall 416. In some embodiments, expanding the expandable balloon 408 biases the needle assembly tube 409 against the container wall, such that the needle assembly 406 is configured to puncture through the container wall as it extends from the needle assembly tube. In some embodiments, the expandable balloon 408 is operably in communication with a mechanism configured to supply a gas (e.g., air) to the expandable balloon, whereby the balloon is expanded. In some embodiments, the gas is supplied via a supply line connecting a gas source (e.g., outside the subject) to the device. In some embodiments, the device comprises a stored supply of gas for expanding the expandable balloon 408. In some embodiments, the gas is supplied via an automatic controller. In some embodiments, the gas is supplied via manual input.

[0088] FIG. 17 shows an exemplary embodiment of a needle assembly 406 extending toward a target nerve 418. In some embodiments, the expansion of the balloon 408 enables the needle assembly 406 to extend toward the target nerve. As described herein, in some embodiments, a needle assembly push stem (or other structure) is provided within the catheter body 410, configured to engage the needle assembly 406 and push it toward the target nerve. In some embodiments, the push stem is located within the catheter body 410 and configured to operate to automatically push the needle assembly 406. In some embodiments, the automatic operation of the push stem is initiated by a wireless or wired signal provided by the user. In some embodiments, the push stem is configured to be manually pushed out by the user (via a mechanism extending from the device to the outside of the subject). In some embodiments, the needle assembly 406, e.g., the needle port 412, is configured to extend a predetermined distance from the needle assembly lumen 409 such that it contacts or is positioned proximate to the target nerve 418 (e.g., the GSN as described herein). In some embodiments, the needle assembly is configured to extend at a non-zero angle relative to the longitudinal axis 403. In some embodiments, the needle assembly 406 is configured to rotate about the needle assembly axis. In some embodiments, the needle assembly is configured to be rotated by the push stem. In some embodiments, the needle assembly 406 is configured to be guided in a rotational direction until the needle is positioned in the direction of the target nerve (e.g., the GSN).

[0089] Continuing to refer to FIG. 17, the needle assembly 406 extends toward the target nerve at a location between two portions of the target nerves 418, 419. As described herein, the catheter body 410 is configured to be rotatable to orient the needle assembly 406 (relative to the target nerve) in a predetermined direction, which includes a needle port 412. In some embodiments, the needle port 412 penetrates the target nerve to deliver chemical ablation therein. In some embodiments, the needle port 412 delivers chemical ablation onto and around the outer surface of the target nerve. Thus, chemical delivery enables ablation of the target nerve (e.g., circumferential lysis) along the length from the target nerve location 418 to the target nerve location 419. In some embodiments, the areas around the target nerves 418, 419 represent ablation zones at a given location, and the portion of the target nerve between the portions 418, 419 represents the length of the ablation zone. In some embodiments, as described herein, the longer the length of the ablation zone, the longer the treatment period for the medical conditions (e.g., heart failure) described herein is provided.

[0090] In some embodiments, the hollow needle stem 414 is operably in communication with a mechanism configured to supply a chemical substance to the needle assembly. In some embodiments, the chemical substance is supplied via a supply line that connects a chemical substance source (e.g., outside the subject) to the device. In some embodiments, the device includes a stored supply of the chemical substance for delivery to or around the target nerve. In some embodiments, the chemical substance is supplied via an automatic controller. In some embodiments, the chemical substance is supplied via manual input. In some embodiments, the chemical substance includes carbon dioxide, ethanol, liquid nitrogen, a conductive substance (e.g., saline solution, a special hydrogel, etc.), or combinations thereof.

[0091] In some embodiments, the electrode region 407 is configured to provide stimulation to a target nerve (e.g., via the nerve stimulation electrodes described herein). In some embodiments, the electrode region is positioned within the subject at a location corresponding to the target nerve (e.g., the location may be perpendicular to the axis of the catheter body 410) (e.g., for use with radiopaque markers and / or nerve perception regions). Thus, in some embodiments, the stimulation is provided via a signal delivered perpendicularly. In some embodiments, the configuration of the needle assembly extending from the catheter body correlates with the positioning of the electrode region 407.

[0092] Figures 18 - 21 illustrate an exemplary process for treating a medical condition as described herein, the process being classified into four components of the exemplary process: diagnosis, general treatment, site recognition / confirmation, and ablation. Figure 19 shows exemplary steps of the general treatment category, including patient preparation steps such as introducing a device (e.g., a catheter device) into the subject and advancing the device to a predetermined location.

[0093] Figure 20 shows exemplary steps of the site recognition / confirmation category, including confirming the location of the target nerve via detected nerve stimulation and corresponding nerve activity and / or physiological changes (e.g., sympathetic response). Figure 21 shows exemplary steps of the ablation category, including various ablation modalities such as from a vein, artery, or intravascularly (e.g., ultrasound, linear electrode array), through the vein wall (e.g., see Figures 6, 13, and 17), and into the vein wall.

[0094] Figures 23A - 27B depict exemplary depictions of the device 2300 described herein. The telescoping needle assembly includes an extendable needle and an electrode assembly. The first section surrounds the second section, and the second section extends outwardly from the first section and is used to ablate a target nerve. In some embodiments, referring to FIGS. 23A / B, the device includes a catheter shaft 2311, a handle 2306, a contrast port 2301, a guidewire port 2302, a catheter rotation knob 2303, an electrode advance device 2304, a rotary electrical connector 2305, a catheter tip 2316, an ablation needle exit port 2312, an ablation needle lumen 2314, a guidewire lumen 2318, a marker band 2317, a second marker band 2315, and a needle assembly 2313 including one or more electrodes (e.g., for nerve stimulation or nerve ablation). FIG. 23B shows the needle assembly 2319 fully extended from the device. In some embodiments, the catheter, the ablation needle, the guidewire port 2302, the contrast port 2301, and the rear connector 2305 rotate together. In some embodiments, the guidewire is inserted into the guidewire port 2302 and used to drive the catheter within a blood vessel lumen. In some embodiments, the contrast port 2302 is used for insertion of fluoroscopic contrast. In some embodiments, the rear connector includes pins for two ablation poles and three nerve stimulation and nerve monitoring leads. In some embodiments, the keyway within the handle 2306 couples the rotation of the control knob and the control catheter to the rear electrical connector and routes the electrical connection to allow continuous rotation. In some embodiments, the electrode advance device provides sufficient movement for the distal end of the ablation needle (e.g., the needle assembly) to extend about 1 - 2 cm, in some cases 1.5 cm, from the catheter midline. In some embodiments, the needle assembly including one or more electrodes is not extended. In some embodiments, the needle assembly including one or more electrodes is extended. In some embodiments, the electrode advance device 2304 is used to extend the electrode assembly into vascular tissue, e.g., to puncture vascular tissue.In some embodiments, the guidewire is inserted into the guidewire lumen to advance the catheter tip 2316 into the intravascular space. In some embodiments, the electrode advance device advances the first tubular body of the needle assembly with the first proximal electrode, and then the second tubular body extends from the first tubular body, and the extended length of the telescopic electrode assembly can be controlled by the user. In some embodiments, the guidewire advances separately from the needle assembly with one or more electrodes. In some embodiments, the rear electrical connector has three pins for nerve sensing and two bipolar ablation poles. In some embodiments, the length of the catheter is about 25 to 150 cm, and in some cases, 120 cm. In some embodiments, the nerve sensing element senses one or more electrodes on the catheter shaft substrate that are wound around the catheter shaft 2311 and joined in place. In some embodiments, one or more electrodes on the needle assembly are nerve sensing elements. In some embodiments, one or more electrodes on the catheter shaft, or one or more electrodes on the needle assembly, are used to observe the patient's heart rate and to confirm the pre-ablation needle placement via low-power stimulation. In some embodiments, the device includes a radiopaque region 404 that can be used to assist in tracking the location of the device within the subject. In some embodiments, the radiopaque region is located at any location on the catheter body. In some embodiments, the radiopacity helps to enable the rotational accuracy for positioning the needle assembly (as described herein). In some embodiments, the radiopaque marks appear different on the catheter body in 90-degree increments, thereby helping to orient the needle assembly in the up / down, front / back, outer / inner, and / or cranial / caudal directions. In some embodiments, the charge is delivered from a first electrode that can be positive to a second electrode that can be negative, thereby transmitting energy to the nearby vascular tissue and heating it to about 40 °C, 50 °C, or 60 °C.

[0095] Referring to FIGS. 24A / B, an exemplary depiction of the catheter tip 2400 of device 2420 is shown. In some embodiments, referring to FIG. 24A, the catheter tip includes a guidewire lumen 2401, marker bands 2402 / 2403, an ablation needle exit port 2404, and a needle assembly 2313 having one or more electrodes, such as silk screen electrodes. In some embodiments, referring to FIG. 24B, device 2420 includes a contrast port 2301, a guidewire port 2302, a catheter rotation knob 2303, an electrode advance 2304, a rotary electrical connector 2305, a rotary coupler 2421, and a rotary coupler 2422. In some embodiments, device 2420 is device 2300. In some embodiments, device 2420 does not include contrast port 2301.

[0096] Referring to FIG. 28, a depiction of an exemplary second catheter tip 2800 is shown. In some embodiments, the second catheter tip 2800 includes a guide wire lumen 2820 and an ablation needle lumen 2810 that includes an ablation needle exit port 2811. In some embodiments, the ratio of the radius of curvature of the ablation needle lumen 2810 proximal to the ablation needle exit port 2811 to the diameter of the ablation needle lumen 2810 is from about 1:1 to about 3:1. In some embodiments, the ratio of the radius of curvature of the ablation needle lumen 2810 proximal to the ablation needle exit port 2811 to the diameter of the ablation needle lumen 2810 is at least about 1:1. In some embodiments, the ratio of the radius of curvature of the ablation needle lumen 2810 proximal to the ablation needle exit port 2811 to the diameter of the ablation needle lumen 2810 is at most about 4:1. In some embodiments, the ratio of the radius of curvature of the ablation needle lumen 2810 proximal to the ablation needle exit port 2811 to the diameter of the ablation needle lumen 2810 is in the range of 1:1 to 4:1. In some embodiments, the ratio of the radius of curvature of the ablation needle lumen 2810 proximal to the ablation needle exit port 2811 to the diameter of the ablation needle lumen 2810 is 1:1, 2:1, 3:1, or 4:1. In some embodiments, the ratio of the radius of curvature of the ablation needle lumen 2810 proximal to the ablation needle exit port 2811 to the diameter of the ablation needle lumen 2810 is about 1.8. In some embodiments, this ratio reduces the mechanical stress and resulting forces required to deploy the needle while allowing for the use of larger needles. In some embodiments, the radius of curvature of the needle assembly passage is 0.09 inches. In some embodiments, an increase in the radius of curvature of the needle assembly passage allows for smoother insertion and retraction of the flexible needle assembly. In some embodiments, an increase in the radius of curvature of the needle assembly passage allows for a point of contact at a substantially orthogonal angle between the flexible needle assembly and the target tissue.In some embodiments, an increase in the radius of curvature of the lumen of the needle assembly and the curvature angle of the lumen of the needle assembly bias the vascular catheter relative to a single direction of extension of the expandable needle assembly within the vein, prevent movement of the vascular catheter within the vein when extending the expandable needle assembly, and provide correct insertion of the needle to target an area proximate the target nerve. In some embodiments, the inner diameter of the needle assembly passage is at least 0.033 inches. In some embodiments, the inner diameter of the needle assembly passage is 0.033 inches. In some embodiments, the guidewire lumen is linear, does not curve around the needle assembly passage, and has the same spread as at least a portion of the needle assembly passage. In some embodiments, a linear guidewire lumen having the same spread as a portion of the lumen of the needle assembly results in a linear guidewire lumen that does not require bending of the guidewire within the shaft as force is provided to the catheter device and it advances through the vein, and is thus more easily positioned and guided to a fixed position.

[0097] Referring to FIGS. 25A / B, an exemplary depiction of the telescoping needle assembly 2500 of device 2300 is shown. In some embodiments, as shown in FIG. 25A, the needle assembly includes an enamel-coated wire 2501, a proximal laser-cut hypo tube 2502 that can be a tubular body, a proximal laser-cut hypo tube polyimide insulator 2503, a first electrode band 2504, a second electrode band 2510, a laser-cut hypo tube dielectric washer 2506, an inner polyimide liner 2505, a distal polyimide cover 2509, a distal laser-cut hypo tube 2508 that can be a tubular body, and a solder paste or laser weld 2507. The needle assembly can terminate at a point configured to puncture vascular tissue. In some embodiments, the enamel-coated wire 2501 conducts electricity to one or more electrodes positioned on the outer surface of the needle assembly, such as on the outer surface of the proximal laser-cut hypo tube 2502 (e.g., a tubular body) or on the outer surface of the distal laser-cut hypo tube 2508 (e.g., a tubular body). In some embodiments, the laser-cut hypo tube dielectric washer 2506 and the inner polyimide liner 2505 are insulated. In some embodiments, one or more electrodes 2504 / 2510 are electrical electrodes on the ablation needle assembly 2500 and can be marker bands. In some embodiments, referring to FIG. 25B, the needle assembly includes a longitudinal axis 2512, a distal laser-cut hypo tube 2508 (e.g., a tubular body), a first electrode 2504, a second electrode 2510, and a proximal laser-cut hypo tube 2502 (e.g., a tubular body).

[0098] Referring to FIGS. 26A / B, an exemplary depiction of the telescoping needle assembly 2600 of device 2300 is shown. The telescoping needle assembly may comprise a first section surrounding a second section, the second section extending outwardly from the first section. In some embodiments, the first section includes a first tubular body, the second section includes a second tubular body, the first tubular body extends outwardly from the second tubular body, and the first tubular body is nested within the second tubular body such that the tubular bodies are fully or partially received within the first tubular body. In some embodiments, referring to FIG. 26A, the needle assembly comprises a multi-warp braid 2601 that may be conductive, a proximal laser cut hypo tube 2502 (e.g., a tubular body), a proximal laser cut hypo tube polyimide insulator 2503, a first electrode 2504, a second electrode 2510, a laser cut hypo tube dielectric washer 2506, an inner polyimide liner 2505, a distal polyimide cover 2509, a distal laser cut hypo tube 2508 (e.g., a tubular body), and solder paste or laser weld 2507. The needle assembly may terminate at a point configured to pierce vascular tissue. In some embodiments, the multi-warp braid 2601 conducts electricity to one or more electrodes 2504 / 2510 positioned on the outer surface of the needle assembly, such as, for example, on the outer surface of the proximal laser cut hypo tube 2502 (e.g., a tubular body) or on the outer surface of the distal laser cut hypo tube 2508 (e.g., a tubular body). In some embodiments, the laser cut hypo tube dielectric washer 2506 and the inner polyimide liner 2505 are insulated. In some embodiments, one or more electrodes 2504 / 2510 are electrical electrodes on the ablation needle assembly 2600 and may be marker bands. In some embodiments, referring to FIG. 26B, the needle assembly includes a longitudinal axis 2512, a distal laser cut hypo tube 2508, a marker band 2504, a marker band 2510, and a proximal laser cut hypo tube 2502. In some embodiments, the needle assembly further comprises a third section including a sharp distal point, the second section surrounding the third section, the third section extending outwardly from the second section.

[0099] Referring to FIG. 27, an exemplary depiction of a telescoping needle assembly with the electrode assembly 2700 of the device 2300 is shown. In some embodiments, the telescoping needle assembly comprises a first section surrounding a second section, and the second section extends outwardly from the first section. In some embodiments, the first section includes a first tubular body, the second section includes a second tubular body, the first tubular body extends outwardly from the second tubular body, and the first tubular body is nested within the second tubular body, whereby the tubular body is fully or partially received within the first tubular body. In some embodiments, the needle assembly further comprises a third section including a sharp distal point, the second section surrounds the third section, and the third section extends outwardly from the second section. In some embodiments, referring to FIG. 27A, the assembly includes an enamel-coated wire 2701 / 2702, a rear keyhole 2703, a front keyhole 2704, a rotary hub 2705, a proximal support tube 2706 (e.g., a tubular body), a distal laser-cut hypo tube 2707 (e.g., a tubular body), and a distal laser-cut hypo tube tip 2708 (e.g., a tubular body that may terminate at a point). In some embodiments, the distal laser-cut hypo tube 2707 (e.g., a tubular body) is joined to the support tube 2706 with conductive epoxy. In some embodiments, the proximal enamel-coated wire 2702 is colored and disposed between the proximal support tube 2706 and the rotary hub 2705 before being joined using conductive epoxy. In some embodiments, the distal laser-cut hypo tube 2707 (e.g., a tubular body) extends to a first length, at which point a second portion of the distal laser-cut hypo tube tip 2708 (e.g., a tubular body) extends. In some embodiments, referring to FIG. 27B, there is a cross-sectional view of 2700. In some embodiments, the cross-sectional view has a vertical axis 2710. In some embodiments, the cross-sectional view includes a needle lumen 2314, an enamel-coated wire 2701, a proximal support tube 2706, a distal laser-cut hypo tube 2707, and an inner polyimide liner 2505. FIG. 27B is a telescoping nested of some embodiments of the needle assembly.In some embodiments, there can be a needle lumen that encapsulates therein a proximal support tube 2706 (e.g., a tubular body), therein encapsulates a distal laser cut hypo tube 2707 (e.g., a tubular body), therein encapsulates a proximal support tube 2706 (e.g., a tubular body), and therein encapsulates a conductive wire, e.g., an enamel coating 2701. The distal laser cut hypo tube 2707 (e.g., a tubular body) extends farthest from the longitudinal axis of the catheter and can penetrate the wall of the blood vessel lumen in which the catheter is positioned. When the proximal support tube 2706 (e.g., a tubular body) extends completely, the distal laser cut hypo tube 2707 (e.g., a tubular body) can extend outwardly from the proximal support tube 2706 so that the needle assembly can extend completely. The needle can be nested within itself in a telescoping configuration where the distal laser cut hypo tube 2707 (e.g., a tubular body) extends from within the proximal support tube 2706 (e.g., a tubular body) and the proximal support tube 2706 (e.g., a tubular body) extends outwardly from the catheter.

[0100] Referring to FIGS. 29A / B, an exemplary depiction of a telescoping needle assembly 2900 of the device is shown. The telescoping needle assembly 2900 can include a jacketed wire 2901, a distal laser cut hypo tube 2902, a proximal laser cut hypo tube 2903, a first jacket 2904, a second jacket 2905, a pole separator 2906, a marker band 2908 positioned within the laser cut hypo tube, and an end cap 2907. In some embodiments, the first jacket can be omitted. In some embodiments, the increased diameter of the distal laser cut hypotube 2902 and the proximal laser cut hypotube 2903 provides an increased outer electrode surface area for distributing the applied current over a larger tissue area, and thus provides an increased energy application while reducing the risk / possibility of burning or carbonization of the tissue receiving the current, where the tissue adheres to the electrode surface and is pulled out with the needle assembly during retraction. In some embodiments, the ratio of the diameter of the distal laser cut hypotube 2902, the proximal laser cut hypotube 2903, or both, to the surface area per inch is from about 0.05 to about 0.4. In some embodiments, the ratio of the diameter of the distal laser cut hypotube 2902, the proximal laser cut hypotube 2903, or both, to the surface area per inch is about 0.32. In some embodiments, the ratio of the diameter of the distal laser cut hypotube 2902, the proximal laser cut hypotube 2903, or both, to the surface area per inch is about 0.05, 0.1, 0.2, 0.3, or 0.4, including increments therebetween. In some embodiments, the ratio of the diameter of the flexible needle assembly and one or more electrodes to the surface area per inch is at least 0.05. In some embodiments, the ratio of the diameter of the flexible needle assembly and one or more electrodes to the surface area per inch is from about 0.05 to about 0.15. In some embodiments, the ratio of the diameter of the flexible needle assembly and one or more electrodes to the surface area per inch is at most 0.15. In some embodiments, the distal laser cut hypotube 2902 and the proximal laser cut hypotube 2903 are flexible and provide both column strength for penetrating tissue and tensile strength to prevent the ablation needle electrode from expanding / stretching during storage in the catheter. In some embodiments, the marker band 2907 enables visualization of the flexible needle assembly 2900 during use while preventing snagging on tissue due to its placement within the hypotube to reduce migration around the outer surface of the hypotube and maintain a smooth surface around the outer surface of the hypotube. In some embodiments, the pole separator 2906, the first jacket 2904, the second jacket 2905, or any combination thereof is made of a non-ferrous electrical insulating material. In some embodiments,

[0101] In some embodiments, each of the one or more electrodes has a surface area of at least about 0.01 square inches, 0.0125 square inches, 0.015 square inches, 0.0175 square inches, or more, including its increment. In some embodiments, the one or more electrodes have a surface area of from about 0.02 square inches to about 0.03 square inches. In some embodiments, the one or more electrodes have, including its increment, from about 0.02 square inches to about 0.021 square inches, from about 0.02 square inches to about 0.022 square inches, from about 0.02 square inches to about 0.023 square inches, from about 0.02 square inches to about 0.025 square inches, from about 0.02 square inches to about 0.0255 square inches, from about 0.02 square inches to about 0.026 square inches, from about 0.02 square inches to about 0.0275 square inches, from about 0.02 square inches to about 0.028 square inches, from about 0.02 square inches to about 0.029 square inches, from about 0.02 square inches to about 0.03 square inches, from about 0.021 square inches to about 0.022 square inches, from about 0.021 square inches to about 0.023 square inches, from about 0.021 square inches to about 0.025 square inches, from about 0.021 square inches to about 0.0255 square inches, from about 0.021 square inches to about 0.026 square inches, from about 0.021 square inches to about 0.0275 square inches, from about 0.021 square inches to about 0.028 square inches, from about 0.021 square inches to about 0.029 square inches, from about 0.021 square inches to about 0.03 square inches, from about 0.022 square inches to about 0.023 square inches, from about 0.022 square inches to about 0.025 square inches, from about 0.022 square inches to about 0.0255 square inches, from about 0.022 square inches to about 0.026 square inches, from about 0.022 square inches to about 0.0275 square inches, from about 0.022 square inches to about 0.028 square inches, from about 0.022 square inches to about 0.029 square inches, from about 0.022 square inches to about 0.03 square inches, from about 0.023 square inches to about 0.025 square inches, from about 0.023 square inches to about 0.0255 square inches, from about 0.023 square inches to about 0.026 square inches, from about 0.023 square inches to about 0.0275 square inches, from about 0.023 square inches to about 0.028 square inches, from about 0.023 square inches to about 0.029 square inches, from about 0.023 square inches to about 0.03 square inches, from about 0.025 square inches to about 0.Having a surface area of 0.255 square inches, from about 0.025 square inches to about 0.026 square inches, from about 0.025 square inches to about 0.0275 square inches, from about 0.025 square inches to about 0.028 square inches, from about 0.025 square inches to about 0.029 square inches, from about 0.025 square inches to about 0.03 square inches, from about 0.0255 square inches to about 0.026 square inches, from about 0.0255 square inches to about 0.0275 square inches, from about 0.0255 square inches to about 0.028 square inches, from about 0.0255 square inches to about 0.029 square inches, from about 0.0255 square inches to about 0.03 square inches, from about 0.026 square inches to about 0.0275 square inches, from about 0.026 square inches to about 0.028 square inches, from about 0.026 square inches to about 0.029 square inches, from about 0.026 square inches to about 0.03 square inches, from about 0.0275 square inches to about 0.028 square inches, from about 0.0275 square inches to about 0.029 square inches, from about 0.0275 square inches to about 0.03 square inches, from about 0.028 square inches to about 0.029 square inches, from about 0.028 square inches to about 0.03 square inches, or from about 0.029 square inches to about 0.03 square inches. In some embodiments, one or more electrodes have a surface area of about 0.02 square inches, about 0.021 square inches, about 0.022 square inches, about 0.023 square inches, about 0.025 square inches, about 0.0255 square inches, about 0.026 square inches, about 0.0275 square inches, about 0.028 square inches, about 0.029 square inches, or about 0.03 square inches. In some embodiments, one or more electrodes have a surface area of at least about 0.02 square inches, about 0.021 square inches, about 0.022 square inches, about 0.023 square inches, about 0.025 square inches, about 0.0255 square inches, about 0.026 square inches, about 0.0275 square inches, about 0.028 square inches, or about 0.029 square inches. In some embodiments, one or more electrodes have a surface area of at most about 0.021 square inches, about 0.022 square inches, about 0.023 square inches, about 0.025 square inches, about 0.0255 square inches, about 0.026 square inches, about 0.0275 square inches, about 0.028 square inches, about 0.029 square inches, or about 0.03 square inches.

[0102] The telescopic needle assemblies disclosed herein have several beneficial technical effects, including improved ablation, reduced trauma, smoother insertion and retraction of the needle assemblies, ease of manufacture, and increased control of ablation parameters and ablation length. For example, the telescopic configuration of the needle assembly can mainly extend in a linear (or relatively linear) vector that does not move the tissue adjacent to the telescopic needle assembly, so that it penetrates the vascular tissue and minimizes the sharp force trauma to other tissues that surround the target nerve when extended. It can be more advantageous than alternative configurations. Furthermore, it is telescopic and, compared to a bifurcated configuration, is more likely to extend and contract properly without capturing vascular tissue within the needle assembly or between the components of the needle assembly. In some cases, the length of the extension of the telescopic needle assembly with an electrode assembly can be controlled by the operator, the length between the electrodes on the telescopic needle assembly can vary, and in a configuration with a large displacement between the electrodes, it allows an increase in the ablation length, or in a configuration with a small displacement between the electrodes, it allows a decrease in the ablation length. In some embodiments, the ease of extension of the telescopic needle assembly can improve the operator's ability to achieve or maintain a desired electrode displacement, such as a desired electrode displacement, or a desired displacement from or proximal to the target nerve, in order to achieve desired ablation parameters. The telescopic needle assembly can also be easier to manufacture compared to a bifurcated assembly, such that a first section can be nested within a second section of the needle assembly.

Example

[0103] Example 1: Nerve Ablation Catheter with a Bifurcated Needle Assembly A vascular catheter device comprising a needle assembly is provided. Referring to FIGS. 2 and 3, the device includes a device body (e.g., a catheter body) 210, a catheter tip 202, a needle assembly 206 configured to be disposed within the catheter body, an opening 208 through which the needle assembly 206 extends therefrom, and an electrode region 207 (e.g., for nerve stimulation). The opening 208 is a side opening, and the device body 210 has a longitudinal axis (203). The electrode region may also be located at any location on the catheter body 210, in the same location as a nerve sensory region (e.g., for measuring action potentials). The device includes a radiopaque region 204 that can be used to assist in tracking the location of the device within the subject. The radiopaque region is located at any location on the catheter body and serves to enable rotational accuracy for positioning the needle assembly (as described herein). The device further includes radiopaque marks at different locations on the catheter body in 90-degree increments, thereby serving to orient the needle assembly in the up / down, front / back, outer / inner, and / or cranial / caudal directions. The device body further includes a needle lumen that extends within the device body and terminates at a side opening. The needle assembly includes two needle electrodes, each having a separate needle.

[0104] A needle assembly push stem (or other structure) is provided within the catheter body 210 and is configured to engage the needle assembly to push the needle assembly 206 through the opening 208. In some embodiments, the push stem is located within the catheter body 210 and is configured to actuate to automatically extrude the needle assembly 206 from the opening 208 when actuated by a user via an actuating member on a handle device. The needle assembly 206 is provided within a needle assembly tube located within the catheter body 210. The tube is configured to extend from the opening 208 to the vein wall, and the needle assembly is then configured to extend from the end of the tube and pierce through the vein wall.

[0105] The catheter body 310 is configured to rotate to orient the needle assembly 306 in a predetermined direction with respect to the target nerve. The needle assembly is configured to extend from the catheter body according to a particular configuration, which corresponds to the location of a radiopaque marker (e.g., 304) such that the direction and position of the electrodes on the needle assembly during expansion can correlate with the location of the radiopaque marker. The radiopacity serves to enable the rotational accuracy for positioning the needle assembly (as described herein). The radiopaque marks appear different on the catheter body in 90-degree increments, thereby serving to orient the needle assembly in the up / down, front / back, outer / inner, and / or cranial / caudal directions.

[0106] The electrodes 212, 213 are configured to ablate (e.g., circumferentially lesion) a target nerve of a certain length, which is at least the length from the target nerve location 220 to the target nerve location 221. The areas 220, 221 around the target nerve represent the ablation zone (at a given location), and the portion of the target nerve between the portion 220 and the portion 221 represents the length of the ablation zone. As described herein, the longer the length of the ablation zone, the longer the treatment period for the medical conditions (e.g., heart failure) described herein is provided.

[0107] Example 2: Nerve Ablation Catheter with a Telescoping Needle Assembly A vascular catheter device comprising a needle assembly is provided. Referring to FIGS. 23-27, the device includes a catheter shaft 2311, a handle 2306, a contrast port 2301, a guidewire port 2302, a catheter rotation knob 2303, an electrode advance device 2304, a rotary electrical connector 2305, a catheter tip 2316, an ablation needle exit port 2312, an ablation needle lumen 2314, a guidewire lumen 2318, a marker band 2317, two marker bands 2315, and a silk screen electrode 2313 (e.g., for nerve stimulation). A telescoping needle assembly having one or more electrodes can be extended as shown in FIG. 23B at 2319. The telescoping needle assembly includes a first section surrounding a second section, and the second section extends outwardly from the first section. The first section includes a first tubular body, the second section includes a second tubular body, the first tubular body extends outwardly from the second tubular body, and the first tubular body is nested within the second tubular body such that the tubular bodies are fully or partially received within the first tubular body. In some embodiments, the needle assembly further includes a third section including a sharp distal point, the second section surrounds the third section, and the third section extends outwardly from the second section. In some embodiments, the catheter, ablation needle, guidewire port 2302, contrast port 2301, and rear connector 2305 rotate together. In some embodiments, a guidewire can be inserted into the guidewire port 2302 that drives the catheter within vascular tissue. In some embodiments, the contrast port 2302 is used for fluoroscopic contrast. In some embodiments, the rear connector includes pins for two ablation poles and three nerve stimulation and nerve monitoring leads. In some embodiments, a keyway within the handle 2306 couples rotation of the control knob and control catheter to the rear electrical connector and routes the electrical connection to allow continuous rotation. In some embodiments, the electrode advance device provides sufficient movement such that the distal end of the ablation needle extends approximately 1.5 cm from the catheter midline.In some embodiments, the electrode pusher 2304 is used to extend the electrode assembly into vascular tissue, for example, to puncture the vascular lumen within which the catheter is located, and the extended length of the telescoping electrode assembly can be controlled by the user. In some embodiments, the guide wire is inserted into the guide wire lumen to advance the catheter tip 2316 into the intravascular space. In some embodiments, the electrode pusher advances the outermost electrode and then a second portion extends from the first portion. In some embodiments, the guide wire advances separately from the electrode. In some embodiments, the rear electrical connector has three pins for nerve sensing and two bipolar ablation poles. In some embodiments, the length of the catheter is about 120 cm. In some embodiments, the nerve sensing element is an electrode 2313 on a catheter shaft substrate that is wound around the catheter shaft 2311 and joined in place. In some embodiments, one or more electrodes on the needle assembly are used to observe the patient's heart rate and to confirm the placement of the needle prior to ablation via low-power stimulation. In some embodiments, the device includes a radiopaque region 404 that can be used to assist in tracking the location of the device within the subject. In some embodiments, the radiopaque region is located at any location on the catheter body. In some embodiments, the radiopacity helps to enable rotational accuracy for positioning the needle assembly (as described herein). In some embodiments, the radiopaque marks appear different on the catheter body in 90-degree increments, thereby helping to orient the needle assembly in the up / down, front / back, outer / inner, and / or cranial / caudal directions. In some embodiments, charge is delivered from a first electrode, which can be positive, to a second electrode, thereby transmitting energy to nearby vascular tissue and heating it to about 40 °C, 50 °C, or 60 °C.

[0108] The needle assembly push stem (or other structure) is provided within the catheter shaft 2311 and is configured to engage the needle assembly, such that the needle assembly 2500, or in other embodiments, the needle assembly 2600, is pushed through the ablation needle exit port 2315. In some embodiments, the push stem is located within the catheter shaft 2311 and is configured to actuate to advance the needle assembly 2500, or in other embodiments, the needle assembly 2600, from the ablation needle exit port 2315 when actuated by a user via an actuating member on the handle device. The needle assembly 2500, or in other embodiments, the needle assembly 2600, is provided within a catheter assembly tube located within the catheter shaft 2311. The electrodes within the needle assembly 2500, or in other embodiments, the needle assembly 2600, are configured to extend from the ablation needle exit port 2315 to the vein wall, and then the needle assembly is configured to extend from the end of the tube and pierce through the vein wall.

[0109] The catheter shaft 2311 is configured to rotate to orient the needle assembly 2500, or in other embodiments, the needle assembly 2600, in a predetermined direction with respect to the target nerve. The needle assembly is configured to extend from the catheter body according to a particular configuration, which corresponds to the location of a radiopaque marker (e.g., 304) such that the direction and position of the electrodes on the needle assembly during expansion can be correlated with the location of the radiopaque marker. The radiopacity serves to enable rotational accuracy for positioning the needle assembly (as described herein). The radiopaque marks appear different on the catheter body in 90-degree increments, thereby serving to orient the needle assembly in the up / down, front / back, outer / inner, and / or cranial / caudal directions.

[0110] The electrode configuration 2700 is configured to ablate (e.g., circumferentially dissolve) a length of the target nerve. As described herein, the longer the length of the ablation zone, the longer the treatment period provided for the medical conditions (e.g., heart failure) described herein.

[0111] Compared to the non-flexible needle assembly of Example 1, a flexible needle assembly can result in improved ablation, reduced trauma to vascular tissue and tissue surrounding the target nerve, smoother insertion and retraction of the needle assembly, ease of manufacture, and increased control of ablation parameters and ablation length. For example, the flexible configuration of the needle assembly can extend in a linear (or relatively linear) vector that does not displace the tissue adjacent to the flexible needle assembly, thereby minimizing sharp force trauma to the vascular tissue it penetrates and other tissues that surround the target nerve when extended. Further, flexibility has a greater tendency to properly extend and contract without capturing vascular tissue within the needle assembly or between components of the needle assembly as compared to a bifurcated configuration. Additionally, the length of the extension of a flexible needle assembly comprising an electrode assembly can be controlled by an operator, the displacement between electrodes on the flexible needle assembly can vary, and in configurations where the displacement between electrodes is large, an increase in ablation length, or in configurations where the displacement between electrodes is small, a decrease in ablation length is enabled. The ease of extension of the flexible needle assembly improves the operator's ability to achieve or maintain a desired electrode displacement for each electrode, for example, to achieve a desired ablation parameter. Similarly, the ease of extension of the flexible needle assembly improves the operator's ability to achieve a desired displacement from or proximal to the target nerve by varying the insertion depth of the flexible needle assembly. Collectively, these features can enable a surgeon to account for the anatomical structures of various patients using a flexible needle assembly. A flexible needle assembly may also be easier to manufacture compared to a bifurcated assembly such that a first section can be nested within a second section of the needle assembly.

[0112] Example 3: Outpatient Treatment of Treatment-Resistant Heart Failure Patients with treatment-resistant heart failure come to a cardiac clinic. The patient explains to the physician that after minimal physical activity, such as walking one city block or going up and down a flight of stairs once, they do not have the energy levels the user had and frequently feel "short of breath" or "out of breath". The patient may have been previously evaluated by other physicians and subsequently referred to the cardiac clinic. The patient exhibits other symptoms indicative of heart failure, such as early fatigue, orthopnea, paroxysmal nocturnal dyspnea, dyspnea on exertion, or palpitations episodes. Previously, the patient had reported being able to walk more than one mile without experiencing symptoms complaints. This patient is already taking Lasix (diuretic or water pill), blood pressure medications, generic pharmaceuticals, or combinations thereof, but there has been no improvement in symptoms complaints. At this time, there are no additional options regarding drug therapy. Physical examination shows evidence of overload (fluid in the lungs, swelling in the legs, jugular venous pressure elevation / pulsation). The cardiologist notices that the patient is a class II or class III severity patient of the New York Heart Association (NYHA) according to the level of exercise capacity. Other criteria or indicators of HF severity include brain natriuretic peptide levels and the number of hospitalizations over a recent time frame (at least one hospitalization in the past year). This patient may or may not have the usual co-morbidities of hypertension, kidney disease, liver disease, high cholesterol, and diabetes, among others. The cardiologist then refers the patient for an endoneural ablation procedure to be performed in the outpatient catheterization laboratory associated with the clinic.

[0113] A catheter-based device as described in Example 2 is utilized. The catheter device accesses the vasculature via the Seldinger technique through the jugular vein. The access sheath is advanced to the superior vena cava under fluoroscopic guidance. The sheath inserts a cannula as it passes through the vein from the superior vena cava, and the guide wire traverses the junction vein. The sheath inserts a cannula from the superior vena cava into the junction vein, and the guide wire traverses the junction vein. Using the anatomical landmark T9, the guide wire can enter the left and / or right molar-intermediate vein branches. Here, assuming that the larger greater splanchnic nerve (GSN) is nearby, the device is introduced over the guide wire at this location.

[0114] This is accomplished by using the marker band of the catheter device when the device reaches a location by an anatomical landmark observable by fluoroscopy (bones, blood vessels, etc.). Optionally, proximity to the target nerve is confirmed by applying stimulation energy at that location and measuring the physiological response to the stimulation, such as a muscle response, nerve activity, or cardiac activity in the abdomen or GI tract. In some cases, the operator uses the nerve stimulation component of the device to deliver charge through an electrode that is strong enough to induce a nerve response but not strong enough to damage tissue. The sympathetic response of the GSN is measured by detecting a detrimental change in pulmonary capillary wedge pressure (PCWP), gastrointestinal changes including increased motility, a change in the amount of sweating on the palm of the hand, a change in temperature for rectal and / or skin measurements, an abnormal change in renal output associated with a change in vasodilation, a change in metabolism (i.e., a decrease in glucose and glucagon release), and an increase in brain natriuretic peptide. By eliciting these responses, the user can confirm proximity to the target nerve. PCWP is obtained using a right heart catheterization procedure routinely performed in a hospital. The right heart catheterization procedure may include percutaneous access through the jugular vein using the Seldinger technique in a sterile fashion. The Swan-Ganz catheter has an inflated balloon that is passed through the superior vena cava, right atrium, and right ventricle to the pulmonary outflow tract. The inflated balloon carries the catheter into the pulmonary artery where it is wedged. Here, the detected pressure is called the pulmonary capillary wedge pressure, which is thought to be equivalent to the left ventricular pressure. The left ventricular pressure is an alternative measurement of the left ventricular diastolic pressure. Assuming no mitral valve disease, PCWP is a measure of the severity of heart failure. A high PCWP indicates a worsening of the severity of heart failure. Each of the other responses is measured by a specific aspect of the device.

[0115] The operator may also optionally use the same electrodes as those used by the nerve stimulation component to directly sense the nerve using another component of the device. If the operator can position the device at the approximate location of the GSN using anatomical landmarks, the device generator is changed to the "nerve sensing" mode. The nerve sensing mode uses the electrodes to read the action potential through the GSN. The electrodes can be separate electrodes located on the surface of the catheter device or one or more electrodes within the needle assembly. Data from the nerve stimulation component and the nerve sensing device are aggregated and communicated to the operator that the device is at the location where nerve ablation is to be performed.

[0116] After the location of the nerve has been confirmed by a combination of nerve stimulation and nerve sensing functions evaluated by the software component of the generator, the vascular access mechanism actuates in the direction of the nerve to perform ablation. The access mechanism can optionally confirm the position using a combination of nerve sensing, nerve stimulation with physiological response, and fluoroscopy to identify anatomical landmarks, as described herein.

[0117] The nerve is then ablated by high frequency ablation by applying electrical stimulation to the electrode assembly. Approximately 50 W of electrical energy is transmitted from the power source to the electrode assembly on the needle assembly proximate to the target nerve, heating the target nerve and surrounding tissue to approximately 60 °C.

[0118] Since the nerve can regenerate, the duration of the effect is basically related to the length of the ablated nerve tissue. In some cases, it is desirable to ablate a longer length of nerve (compared to intravascular ablation) to provide a longer period of removal of sympathetic nerve activity. Thus, the patient will experience relief from heart failure symptoms for a longer period. In some cases, it is desirable to control the direction of the ablation modality. By focusing the ablation modality on the length of the nerve, the operator can minimize collateral damage to other organs.

[0119] Next, the success of the procedure can be evaluated by repeating the combination of nerve sensing, nerve stimulation, and physiological response. The nerve stimulation component of the device delivers charge through electrodes that are strong enough to induce a nerve response but not strong enough to damage tissue. The sympathetic nerve response of the GSN is measured by the physiological changes as described above. The nerve sensing component detects the absence of nerve activity, indicating that the nerve has successfully dissolved circumferentially. If there is a physiological response and / or there is nerve activity sensed by the catheter device, the procedure is considered incomplete. The procedure is repeated to dissolve the nerve circumferentially between two intercostal pairs, at the same site, or at different sites.

[0120] After the procedure is performed, the patient is re-evaluated at the clinic one month later. Here, it is noted that the patient has more energy levels and exercise levels and can walk up two or more flight of stairs without the need to rest. The cardiologist noted that the patient has improved by one NYHA severity class and has had fewer hospitalizations.

[0121] Example 4: Inpatient Treatment of Heart Failure The patient was admitted with worsening heart failure due to fluid overload and had recently repeated hospitalizations. The patient required respiratory support (i.e., oxygen, external ventilation, or intubation) and was receiving intravenous diuretic therapy to remove excess fluid. Other standard treatments were included. This patient may or may not have the usual co-morbidities of hypertension, kidney disease, liver disease, hypercholesterolemia, and diabetes, among others. In this case, the intravenous treatment was unable to adequately remove the fluid, and the patient still showed signs of fluid overload and / or respiratory insufficiency. It was decided to perform an endovascular nerve ablation procedure during the hospitalization.

[0122] A catheter-based device as described in Example 2 is utilized. The catheter device accesses the vasculature via the Seldinger technique through the jugular vein. The access sheath is advanced to the superior vena cava under fluoroscopic guidance. The sheath inserts a cannula as it passes through the vein from the superior vena cava, and the guidewire traverses the junction vein. The sheath inserts a cannula from the superior vena cava into the junction vein, and the guidewire traverses the junction vein. Using the anatomical landmark T9, the guidewire can enter the left and / or right molar-intermediate vein branch. Here, it is assumed that the larger greater splanchnic nerve (GSN) is nearby, and the device is introduced over the guidewire at this location.

[0123] This is accomplished by using the marker band of the catheter device when the device reaches a location by an anatomical landmark observable by fluoroscopy (bones, blood vessels, etc.). Optionally, proximity to the target nerve is confirmed by applying stimulation energy at that location and measuring the physiological response to the stimulation, such as muscle response, nerve activity, or cardiac activity in the abdomen or GI tract. In some cases, the operator uses the nerve stimulation component of the device to deliver charge through an electrode that is strong enough to elicit a nerve response but not strong enough to damage tissue. The sympathetic response of the GSN is measured by detecting an adverse change in pulmonary capillary wedge pressure (PCWP), gastrointestinal changes including increased motility, a change in decreased sweating on the palm, a change in temperature for rectal and / or skin measurement, an abnormal change in renal output associated with vasodilation changes, a change in metabolism (i.e., a decrease in glucose and glucagon release), and an increase in brain natriuretic peptide. By eliciting these responses, the user can confirm proximity to the target nerve. PCWP is obtained using a right heart catheterization procedure routinely performed in the hospital. The right heart catheterization procedure consists of percutaneous access through the jugular vein using the Seldinger technique in a sterile fashion. The Swan-Ganz catheter has an inflated balloon that is passed through the superior vena cava, right atrium, and right ventricle to the pulmonary outflow tract. The inflated balloon carries the catheter into the pulmonary artery where it is wedged. Here, the detected pressure is called the pulmonary capillary wedge pressure, which is thought to be equivalent to the left ventricular pressure. The left ventricular pressure is an alternative measurement of the left ventricular diastolic pressure. Assuming no mitral valve disease, PCWP is a measure of the severity of heart failure. An elevated PCWP indicates a worsening of the severity of heart failure. Each of the other responses is measured by a specific aspect of the device.

[0124] The operator can also optionally directly sense the nerve using another component of the device with the same electrodes used by the nerve stimulation component. If the operator can position the device at the approximate location of the GSN using anatomical landmarks, the device generator is changed to the "nerve sensing" mode. The nerve sensing mode reads the action potential through the GSN using the electrodes. The electrodes can be separate electrodes located on the surface of the catheter device or one or more electrodes within the needle assembly. Data from the nerve stimulation component and the nerve sensing device are aggregated and communicated to the operator that the device is at the location where nerve ablation is to be performed.

[0125] After the location of the nerve has been confirmed by a combination of nerve stimulation and nerve sensing functions evaluated by the software component of the generator, the vascular access mechanism actuates in the direction of the nerve to perform ablation. The access mechanism can optionally confirm the position using a combination of nerve sensing, nerve stimulation with a physiological response, and fluoroscopy to identify anatomical landmarks.

[0126] The nerve is then ablated by radiofrequency ablation by applying electrical stimulation to the electrode assembly. Approximately 50 W of electrical energy is transmitted from the power source to the electrode assembly on the needle assembly proximal to the target nerve, heating the target nerve and surrounding tissue to approximately 60 °C.

[0127] Since the nerve can regenerate, the duration of the effect is basically related to the length of the ablated nerve tissue. In some cases, it is desirable to ablate a longer length of nerve (compared to endovascular ablation), resulting in a longer period of removal of sympathetic nerve activity. Thus, the patient will experience relief from heart failure symptoms for a longer period. In some cases, it is desirable to control the direction of the ablation modality. By focusing the ablation modality on the length of the nerve, the operator can minimize collateral damage to other organs.

[0128] Next, the success of the procedure can be evaluated by repeating the combination of nerve sensing, nerve stimulation, and physiological response. The nerve stimulation component of the device delivers charge through electrodes that are strong enough to induce a nerve response but not strong enough to damage tissue. The sympathetic nerve response of the GSN is measured by the physiological changes as described above. The nerve sensing component detects the absence of nerve activity, indicating that the nerve has been successfully circumferentially lysed. If there is a physiological response and / or if nerve activity is detected by the catheter device, the procedure is considered incomplete. The procedure is repeated to lyse the nerve circumferentially between two intercostal pairs, at the same site, or at different sites.

[0129] After the procedure is performed, the patient's volume status improves and the patient is re-evaluated at the clinic one month later. Here, it is noted that the patient has more energy levels and exercise levels and can walk up two or more flight of stairs without rest. The cardiologist noted that the patient improved by one NYHA severity class and had fewer hospitalizations.

[0130] Example 5: Inpatient treatment of heart failure by an alternative surgical method The patient was admitted with worsening heart failure due to fluid overload and had recently repeated hospitalizations. The patient required respiratory support (i.e., oxygen, external ventilation, or intubation) and was receiving intravenous diuretic therapy to remove excess fluid. Other standard treatments were included. This patient may or may not have the usual co-morbidities of hypertension, kidney disease, liver disease, hypercholesterolemia, and diabetes, among others. In this case, the intravenous treatment was unable to adequately remove the fluid and the patient still showed signs of fluid overload and / or respiratory insufficiency. It was decided to perform an ablation procedure of the visceral nerves during hospitalization.

[0131] A catheter-based device as described in Example 2 is utilized. The catheter device accesses the vasculature via the Seldinger technique through the brachial vein, femoral vein, or subclavian vein. The catheter device may be elongated in proportion to the vein selected for access. The access sheath is moved into the superior vena cava under fluoroscopic guidance. The sheath inserts a cannula as it passes through the vein from the superior vena cava, and the guide wire traverses the junction vein. The sheath inserts a cannula from the superior vena cava into the junction vein, and the guide wire traverses the junction vein. Using the anatomical landmark T10, the device is rotated towards the patient's right side such that the needle points towards the patient's right side from within the junction body, and the position and orientation are confirmed using an X-ray marker. Here, the guide wire may enter between two inter-vertebral pairs, which are, for example, T9 and T10, T10 and T11, T11 and T12, and / or T12 and L1. Here, assuming that the larger greater splanchnic nerve (GSN) is nearby, the device is introduced over the guide wire at this location.

[0132] This is done by using the marker band of the catheter device when the device reaches a location by anatomical landmarks observable by fluoroscopy (bones, blood vessels, etc.). Optionally, proximity to the target nerve is confirmed by applying stimulation energy at that location and measuring the physiological response to the stimulation, such as muscle response, nerve activity, or cardiac activity in the abdomen or GI tract. In some cases, the operator uses the nerve stimulation component of the device to deliver charge through electrodes that are strong enough to induce a nerve response but not strong enough to damage tissue. The sympathetic response of the GSN is measured by detecting an adverse change in pulmonary capillary wedge pressure (PCWP), gastrointestinal changes including increased motility, a change in decreased sweating on the palm, a change in temperature for rectal and / or skin measurements, an abnormal change in renal output associated with vasodilation changes, a change in metabolism (i.e., a decrease in glucose and glucagon release), and an increase in brain natriuretic peptide. By eliciting these responses, the user can confirm proximity to the target nerve. The pressure detected is called the pulmonary capillary wedge pressure, which is thought to be equivalent to the left ventricular pressure. The left ventricular pressure is an alternative measurement of the left ventricular diastolic pressure. Assuming no mitral valve disease, the PCWP is a measure of the severity of heart failure. A high PCWP indicates a worsening of the severity of heart failure. Each of the other responses is measured by a specific aspect of the device.

[0133] The operator can also optionally directly sense the nerve using another component of the device with the same electrodes used by the nerve stimulation component. If the operator can position the device in the approximate location of the GSN using anatomical landmarks, the device generator is changed to the "nerve sensing" mode. The nerve sensing mode uses electrodes to read action potentials through the GSN. The electrodes can be separate electrodes located on the surface of the catheter device or one or more electrodes within a needle assembly. Data from the nerve stimulation component and the nerve sensing device are aggregated and communicated to the operator that the device is in a position to perform nerve ablation.

[0134] After the location of the nerve is confirmed by a combination of nerve stimulation and nerve sensing functions evaluated by the software components of the generator, the vascular puncture mechanism activates in the direction of the nerve to perform ablation. The puncture mechanism can optionally confirm the position using a combination of nerve sensing, nerve stimulation with physiological responses, and fluoroscopy to identify anatomical landmarks.

[0135] Next, the nerve is ablated by high-frequency ablation by applying electrical stimulation to the electrode assembly. Approximately 50 W of electrical energy is transmitted from the power source to the electrode assembly on the needle assembly proximate to the target nerve, heating the target nerve and surrounding tissue to approximately 60 °C.

[0136] Since nerves can regenerate, the duration of the effect is basically related to the length of the destroyed nerve tissue. In some cases, it is desirable to ablate a longer length of nerve (compared to intravascular ablation), resulting in a longer period of removal of sympathetic nerve activity. Thus, the patient will experience relief from heart failure symptoms for a longer period. In some cases, it is desirable to control the direction of the ablation modality. By focusing the ablation modality along the length of the nerve, the operator can minimize collateral damage to other organs.

[0137] Next, the success of the treatment can be evaluated by repeating the combination of nerve sensing, nerve stimulation, and physiological responses. The nerve stimulation component of the device delivers charge through electrodes that are strong enough to induce a nerve response but not strong enough to damage tissue. The sympathetic nerve response of the GSN is measured by the physiological changes as described above. The nerve sensing component detects the absence of nerve activity, indicating that the nerve has successfully dissolved circumferentially. If there is a physiological response and / or there is nerve activity sensed by the catheter device, the treatment is considered incomplete. Repeat the treatment to dissolve the nerve circumferentially, at the same site, or at different sites between two intercostal pairs.

[0138] After the treatment is executed, the patient's volume status is improved and the patient is re-evaluated at the clinic one month later. Here, it is noted that the patient has more energy levels and exercise levels and can walk up two or more flight of stairs without the need to rest. The cardiologist pointed out that the patient has improved by one NYHA severity class and the number of hospitalizations has decreased.

[0139] Example 6: A nerve ablation catheter having a flexible needle assembly with an increased electrode surface area Provided is a first vascular catheter device comprising a flexible needle assembly comprising an ablation needle, two electrodes separated by a PEEK pole separator, an end cap, a core wire, a rotary connector, and a proximal laser cut hypo tube. The needle has an outer diameter of about 0.025 inches and each electrode has a length of about 0.33 inches. The end cap and the core wire are made of stainless steel, the core wire has a diameter of about 0.007 inches and is coated with a polyimide inner insulating jacket. The distal pole and the proximal pole were measured to have resistances of about 62 ohms and about 12.8 ohms, respectively.

[0140] Also provided is a second vascular catheter device comprising a flexible needle assembly comprising an ablation needle, two electrodes separated by a PEEK pole separator, an end cap, a core wire, a rotary connector, and a proximal laser cut hypo tube, but different with respect to the outer diameter of the flexible needle assembly, the length of the electrodes on the flexible needle assembly, and the distal pole resistance and the proximal pole resistance. The needle has an outer diameter of about 0.018 inches and each zone has a length of about 0.39 inches. The core wire is formed of nitinol, has a diameter of about 0.007 inches and is coated with a polyimide inner insulating jacket. The rotary connector is formed of Pebax and polyimide. The distal pole and the proximal pole were measured to have resistances of about 42.5 ohms and about 44.8 ohms, respectively.

[0141] A first vascular catheter device and a second vascular catheter device, each having a telescopic needle assembly, were tested in a poultry tissue model to evaluate the effectiveness of tissue ablation resulting from an improved electrode design.

[0142] The first vascular catheter device was tested by inserting the telescopic needle assembly into the chicken breast meat and delivering electrical energy to the electrodes. After applying 8 W for approximately 30 seconds, no audible sound of vaporization or signs of plasma generation were recorded, and the laser-engraved hypo tube was smoothly removed without tissue adhesion. After applying 9 W for approximately 30 seconds, no audible sound of vaporization or signs of plasma generation were recorded, and the laser-engraved hypo tube was removed with only slight tissue adhesion. An audible sound of vaporization was recorded 27 seconds after applying 10 W without signs of plasma generation, and small pieces of tissue adhered to the laser-engraved hypo tube after extraction. A further application of 10 W for 14 seconds of the formed vaporization sound was reported, but visible plasma and a cooking odor were reported 28 seconds later. By applying 10 W to a new portion of the tissue for approximately 20 seconds, an audible sound of vaporization without signs of plasma occurred. After 30 seconds, the laser-engraved hypo tube was easily removed, and the length and diameter of the ablation zone were measured to be 18.6 mm and 8.34 mm, respectively.

[0143] The second vascular catheter device was tested by inserting the telescopic needle assembly into the chicken breast meat and delivering electrical energy to the electrodes. After applying 8 W for approximately 30 seconds, no audible sound of vaporization or signs of plasma generation were recorded, and the laser-engraved hypo tube was smoothly removed without tissue adhesion or signs of ablation. After applying 9 W for approximately 30 seconds, no audible sound of vaporization or signs of plasma generation were recorded, and the laser-engraved hypo tube was removed with slight tissue adhesion. An audible sound of vaporization was recorded 30 seconds after applying 10 W without signs of plasma generation, and small pieces of tissue adhered to the laser-engraved hypo tube after extraction. The length and diameter of the ablation zone were measured to be 15.2 mm and 5.37 mm, respectively.

[0144] Comparing the above results, the first nerve ablation catheter of the present specification with an increased electrode surface area can sufficiently ablate tissue without plasma-induced carbon damage and can be observed to be removable from the tissue without damaging the tissue surrounding the ablation area. The first vascular catheter device has a short electrode surface length that defines an ablation zone (8.4 mm) shorter than that of the second vascular catheter device (9.9 mm), yet forms an ablation zone that is 22% longer and has a diameter 55% larger than the ablation zone formed by the second vascular catheter device. Thus, the first vascular catheter device shows 195% of the ablation zone compared to the second vascular catheter device (1016 mm 3 for the first catheter versus 344 mm 3 ) for the second catheter), while also reducing tissue adhesion to the needle assembly and showing a decrease in tissue adhesion to the ablation needle when operated for 30 seconds under equivalent conditions of 9 watt application. Therefore, the improved ablation volume provided by the first vascular catheter device with an increased surface area provides the surgeon with greater flexibility in performing ablation procedures and enables ablation of a relatively large volume over a longer period, while also showing a decrease in tissue adhesion to the ablation needle that poses a risk of significant post-ablation damage upon needle retraction.

[0145] Example 7: A telescopic needle assembly with an increased curvature of the needle lumen and a linear guidewire lumen, a nerve ablation catheter A first vascular catheter device is provided that includes a flexible needle assembly having an ablation needle, two electrodes separated by a PEEK pole separator, an end cap, a core wire, a rotary coupler, and a proximal laser cut hypo tube. The vascular catheter device includes a needle assembly lumen having an inner diameter of 0.033 inches and a radius of curvature of 0.09 inches in which the flexible needle assembly extends, and a linear guide wire lumen having the same spread as a portion of the needle assembly lumen. The resulting exit port of the needle assembly lumen is positioned at a substantially orthogonal angle. The first vascular catheter device further includes a tubular body configured to bias the vascular catheter in a single extending direction and prevent movement of the vascular catheter within vascular tissue when extending the flexible needle assembly.

[0146] A second vascular catheter device is provided that includes a flexible needle assembly having an ablation needle, two electrodes separated by a PEEK pole separator, an end cap, a core wire, a rotary coupler, and a proximal laser cut hypo tube. The vascular catheter device includes a needle assembly lumen having an inner diameter of 0.03 inches and a radius of curvature of 0.055 inches in which the flexible needle assembly extends, and a linear guide wire lumen having the same spread as a portion of the needle assembly lumen. The resulting exit port of the needle assembly lumen is positioned at an angle that is less orthogonal than that of the first vascular catheter device.

[0147] Delivery of the catheter device is tested in a porcine model. The catheter is positioned by movement of a guide wire around the guide wire lumen. The first vascular catheter device having a linear guide wire lumen having the same spread as a portion of the needle assembly lumen is observed to be more easily positioned and guided to a fixed position as a result of the linear guide wire lumen, as compared to a non-linear portion guide wire lumen of a second catheter device in which the guide wire needs to be bent within the shaft as force is supplied to the catheter device and it advances through the vein.

[0148] The extension of the telescopic needle assembly is tested in a porcine model. An increase in the radius of curvature of the inner cavity of the needle assembly and the curvature angle of the inner cavity of the needle assembly bias the blood vessel catheter in a single direction of extension of the telescopic needle assembly within the vein and prevent movement of the blood vessel catheter within the vein when extending the telescopic needle assembly.

[0149] Embodiment Embodiment 1. A device for treating a medical condition, the device comprising a catheter having a longitudinal axis and a needle lumen substantially parallel or substantially coincident with the catheter longitudinal axis, the needle lumen terminating at a lateral opening at the distal portion of the catheter, the catheter containing within it the needle lumen, and a needle assembly configured to extend within and / or from the needle lumen, the needle assembly comprising a first needle having a first tip and a second needle having a second tip, the first needle and the second needle being disposed at the distal end of the needle assembly, the needle assembly having A) a non-bifurcated configuration before at least partially extending from the needle lumen and / or the lateral opening, and B) a bifurcated configuration when at least partially extending from the needle lumen and the lateral opening, when the needle assembly is in the bifurcated configuration, the first tip and the second tip being separated by a deployment distance measured from the first tip and the second tip, when the needle assembly is in the non-bifurcated configuration, the first tip and the second tip being separated by a non-bifurcated distance measured from the first tip and the second tip, the deployment distance being greater than the non-bifurcated distance, when the needle assembly is in the bifurcated configuration, each of the first needle and the second needle being at a non-zero angle with respect to the longitudinal axis of the catheter, the first needle and the second needle, a first ablation electrode disposed on the first needle, the first ablation electrode being in electrical communication with a first energy source, the first ablation electrode, a second ablation electrode disposed on the second needle, the second ablation electrode being in electrical communication with the first and / or second energy sources, the second ablation electrode, an embodiment including the device.

[0150] Embodiment 2. The device according to Embodiment 1, wherein the needle assembly extends from the needle lumen, is close to the target nerve, and when energized, is configured to ablate a target nerve having a length that is at least the same as or longer than the deployment distance between the first tip and the second tip.

[0151] Embodiment 3. The device according to Embodiment 1 or 2, further comprising a needle tube within and / or extending from the needle lumen, wherein the needle assembly is at least partially disposed within the needle tube and has a bifurcated configuration when at least partially extending from the needle tube.

[0152] Embodiment 4. A device for treating a medical condition, the device comprising: a catheter having a longitudinal axis; a balloon having a proximal shoulder at a distal portion of the catheter, the balloon being configured to be in fluid communication and expand with an inflation medium; a cannula disposed on an outer surface of the balloon; and a needle assembly configured to extend within and / or from the cannula, the needle assembly comprising a first needle having a first tip and a second needle having a second tip, the first needle and the second needle being disposed at a distal end of the needle assembly, the needle assembly having: A) a non-bifurcated configuration before extending a predetermined distance from the cannula, and B) a bifurcated configuration when extending a predetermined distance from the cannula, wherein when the needle assembly is in the bifurcated configuration, the first tip and the second tip are separated by a deployment distance measured from the first tip and the second tip, and when the needle assembly is in the non-bifurcated configuration, the first tip and the second tip are separated by a non-bifurcated distance measured from the first tip and the second tip, the deployment distance being greater than the non-bifurcated distance; the first needle and the second needle; a first ablation electrode disposed on the first needle, the first ablation electrode being in electrical communication with a first energy source; and a second ablation electrode disposed on the second needle, the second ablation electrode being in electrical communication with the first and / or second energy sources; wherein when the balloon is inflated, the cannula moves at a non-zero angle relative to the longitudinal axis of the catheter. An embodiment including the device. When the needle assembly extends a predetermined distance from the cannula, is in proximity to a target nerve, and is energized, the device is configured to ablate a target nerve having a length that is at least as long as or longer than the deployment distance between the first tip and the second tip. The device according to Embodiment 4.

[0153] Embodiment 5. The device according to Embodiment 4 or 5, wherein the balloon is in fluid communication with an inflation medium that is expandable via an inflation tube.

[0154] Embodiment 6. The device according to any one of Embodiments 4 to 6, wherein the inflation medium includes a gas or a liquid.

[0155] Embodiment 7. The device according to Embodiment 7, wherein the inflation medium contains air, physiological saline, or water.

[0156] Embodiment 8. The device according to any one of Embodiments 1 to 8, wherein the first ablation electrode and the second ablation electrode are electrically insulated from each other.

[0157] Embodiment 9. The device according to any one of Embodiments 1 to 9, wherein the needle assembly is configured to deliver charge in a bipolar mode.

[0158] Embodiment 10. The device according to any one of Embodiments 1 to 10, wherein the first ablation electrode and / or the second ablation electrode is operably communicable with a controller to adjust the power delivered by the first and / or second energy source.

[0159] Embodiment 11. The device according to Embodiment 2 or 5, wherein the length of the target nerve to be ablated is 10% to 1000% longer than the deployment distance.

[0160] Embodiment 12. The device according to any one of Embodiments 1 to 12, wherein the deployment distance is from about 1 mm to about 10 cm.

[0161] Embodiment 13. The device according to any one of Embodiments 1 to 13, wherein the first needle and the second needle contain a memory material, whereby the needle assembly can change to a bifurcated configuration when not constrained within the needle assembly lumen.

[0162] Embodiment 14. The device according to any one of Embodiments 1 to 14, further comprising a nerve stimulation electrode disposed on the outer surface catheter, the nerve stimulation electrode being electrically communicable with the first, second, or third energy source at the proximal end of the device and configured to stimulate the target nerve.

[0163] Embodiment 15. The device according to Embodiment 15, wherein the nerve stimulation electrode is positioned within 0 to 90 degrees radially from a location on the outer surface of the catheter with respect to the longitudinal axis of the catheter on its outer surface.

[0164] Embodiment 16. The device according to Embodiment 16, wherein two or more of the first and second energy sources and the third energy source are the same or different energy sources.

[0165] Embodiment 17. The device according to Embodiment 17, wherein two or more of the first energy source, the second energy source, and the third energy source have different energy parameters or the same energy parameters (such as X, Y, Z).

[0166] Embodiment 18. A device for treating a medical condition, the device comprising: a catheter having a longitudinal axis; a balloon having a proximal shoulder at a distal portion of the catheter, the balloon being configured to be in fluid communication and expand with an inflation medium; a cannula disposed on an outer surface of the balloon; a hollow needle having a needle longitudinal axis and configured to extend within and / or from the cannula, the hollow needle being in fluid communication with an ablation medium and having a lateral needle opening for delivering the ablation medium therefrom; and a nerve stimulation electrode disposed on an outer surface of the catheter, the nerve stimulation electrode being in electrical communication with a first energy source and configured to stimulate a target nerve, wherein when the balloon is inflated, the cannula moves at a non-zero angle with respect to the longitudinal axis of the catheter, and the device is configured to ablate a length of the target nerve via delivery of the ablation medium through the lateral needle opening. One embodiment includes the device.

[0167] Embodiment 19. The device according to Embodiment 19, wherein the balloon is in fluid communication with an inflatable medium via an inflation tube.

[0168] Embodiment 20. The inflation medium is the device according to any one of Embodiments 19 or 20, including a gas or a liquid.

[0169] Embodiment 21. The inflation medium is the device according to Embodiment 21, including air, physiological saline, or water.

[0170] Embodiment 22. The ablation medium is the device according to any one of Embodiments 19 to 22, including a liquid and / or a gas.

[0171] Embodiment 23. The ablation medium includes carbon dioxide, ethanol, liquid nitrogen, a conductive substance (e.g., physiological saline, a special hydrogel, etc.), alcohol, lidocaine, a lidocaine analog, or a combination thereof, and is the device according to any one of Embodiments 19 to 23.

[0172] Embodiment 24. The nerve stimulation electrode is positioned within 0 to 90 degrees radially from a location on the outer surface of the catheter with respect to the longitudinal axis of the catheter on its outer surface, and is the device according to any one of Embodiments 19 to 24.

[0173] Embodiment 25. The device according to any one of Embodiments 1 to 25, further comprising a nerve sensory region configured to sense the nerve activity of the target nerve.

[0174] Embodiment 26. The nerve sensory region of the device according to Embodiment 26 is configured to detect the action potential of the target nerve.

[0175] Embodiment 27. The device according to Embodiment 26 or 27, wherein the nerve sensory region includes a nerve sensory electrode.

[0176] Embodiment 28. The catheter further includes a radiopaque region, and is the device according to any one of Embodiments 1 to 28.

[0177] Embodiment 29. A method for treating a medical condition, the method comprising inserting a catheter into a subject, the catheter having an opening at its distal portion; guiding the catheter to a first position within the subject using an anatomical landmark so as to approach the location of the target nerve; delivering a first stimulus to the target nerve via a nerve stimulation electrode disposed on the catheter; and measuring a physiological response corresponding to the first stimulus, thereby confirming the location of the target nerve.

[0178] Embodiment 30. The method according to embodiment 30, further comprising, prior to step (d): (a) monitoring a physiological parameter; (b) moving the catheter to a second position within the subject so as to approach the location of the target nerve; and (c) delivering a second stimulus to the target nerve via the nerve stimulation electrode.

[0179] Embodiment 31. The method according to embodiment 30 or 31, further comprising sensing nerve activity of the target nerve using a nerve perception region disposed on the catheter before delivering the first stimulus.

[0180] Embodiment 32. The method according to any one of embodiments 30 to 32, further comprising extending a needle assembly from the catheter to the target nerve and ablating a length of the target nerve to provide treatment of the medical condition.

[0181] Embodiment 33. The method according to embodiment 33, wherein the needle assembly comprises an ablation electrode.

[0182] Embodiment 34. The method according to embodiment 33, further comprising bifurcating the needle assembly to space a first needle tip on a first needle from a second needle tip on a second needle before ablating the length of the target nerve, wherein a first ablation electrode is disposed on the first needle and a second ablation electrode is disposed on the second needle, and the ablation is via the first ablation electrode and the second ablation electrode.

[0183] Method according to Embodiment 35, wherein the length of the target nerve is at least as long as or longer than the distance between the first needle tip and the second needle tip after bifurcating the needle assembly.

[0184] Method according to Embodiment 35 or 36, further comprising expanding a balloon disposed on the catheter so as to orient the needle assembly in a direction in which each ablation electrode is aligned with the target nerve before extending the needle assembly from the catheter.

[0185] Method according to any one of Embodiments 35 to 37, wherein ablating at least a portion of the target nerve comprises delivering high-frequency energy, microwave energy, or both to the target nerve.

[0186] Method according to Embodiment 33, wherein the needle assembly comprises a hollow needle having a fluid port, and the hollow needle is in fluid communication with an ablation medium.

[0187] Method according to Embodiment 39, wherein ablating the target nerve of said length comprises delivering an ablation medium to the target nerve via the fluid port.

[0188] Method according to Embodiment 40, wherein the ablation medium comprises carbon dioxide, ethanol, liquid nitrogen, a conductive substance (e.g., physiological saline, a special hydrogel, etc.), alcohol, lidocaine, a lidocaine analog, or a combination thereof.

[0189] Method according to any one of Embodiments 33 to 41, further comprising delivering a third stimulus to the target nerve via a nerve stimulation electrode and confirming interrupted nerve activity of the target nerve.

[0190] Method according to Embodiment 42, wherein confirming interrupted nerve activity comprises detecting an absence or slight change in physiological changes after delivering the third stimulus.

[0191] Embodiment 43. The method according to any one of Embodiments 33 to 43, further comprising rotating the catheter to position the needle assembly such that the needle assembly extends from the catheter to the target nerve.

[0192] Embodiment 44. The method according to any one of Embodiments 30 to 44, wherein guiding the catheter includes using fluoroscopy using a radiopaque region on the catheter.

[0193] Embodiment 45. The method according to any one of Embodiments 30 to 45, wherein the anatomical landmark includes the ninth thoracic vertebra (T9).

[0194] The present invention has been described with reference to exemplary embodiments, but this description is not intended to be construed in a limiting sense. Various modifications and combinations of the exemplary embodiments, as well as other embodiments of the present invention, will be apparent to those skilled in the art in light of the description. Accordingly, the appended claims are intended to embrace such modifications and enhancements.

Claims

[Claim 1] It is a vascular catheter, a. Longitudinal axis, b. The distal end and, c. Proximal end and, d. Catheter shaft equipped with an exit port, e. A retractable needle assembly lumen comprising a retractable needle assembly extending through the exit port and configured to puncture vascular tissue in contact with the catheter, wherein the retractable needle assembly comprises one or more electrodes, the one or more electrodes configured to deliver electrical energy to tissue in contact with the one or more electrodes, the retractable needle assembly comprising a first section surrounding a second section, the second section extending outward from the first section, and the one or more electrodes extending at least 0.02 inches per electrode ２ The lumen of the expandable needle assembly includes the surface area of, f. Guidewire lumen and, g. A vascular catheter equipped with a catheter tip.

Images